Subcutaneous device

ABSTRACT

A subcutaneously implantable device includes a housing, a clip attached to a top side of the housing, and an electrode. The clip is configured to anchor the device to a muscle, a bone, and/or a first tissue. The electrode is configured to contact an organ, a nerve, the first tissue, and/or a second tissue. Circuitry in the housing is in electrical communication with the electrode and is configured to sense an electrical signal from the organ, the nerve, the first tissue, and/or the second tissue through the electrode; deliver electrical stimulation to the organ, the nerve, the first tissue, and/or the second tissue through the electrode; and/or deliver a signal to a drug pump to provide a targeted or systemic therapeutic drug to the organ, the nerve, the first tissue, and/or the second tissue.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This application is a continuation of U.S. Ser. No. 16/051,410, filed onJul. 31, 2018, and entitled “Subcutaneous Device,” the disclosure ofwhich is incorporated by reference in its entirety.

This application is related to U.S. Ser. No. 16/051,446, filed on Jul.31, 2018, entitled “Injectable Subcutaneous Device,” and having AttorneyDocket No. M999-012002, the disclosure of which is incorporated byreference in its entirety.

This application is related to U.S. Ser. No. 16/051,451, filed on Jul.31, 2018, entitled “Subcutaneous Device for Monitoring and/or ProvidingTherapies,” and having Attorney Docket No. M999-012003, the disclosureof which is incorporated by reference in its entirety.

BACKGROUND

The present invention relates to implantable medical devices, and inparticular, to a subcutaneous device.

Implantable medical devices include medical devices that are implantedin the body. Examples of implantable medical devices can include cardiacmonitors, pacemakers, and implantable cardioverter-defibrillators,amongst many others. These implantable medical devices can receivesignals from the body and use those signals for diagnostic purposes.These implantable medical devices can also transmit electricalstimulation or deliver drugs to the body for therapeutic purposes. Forinstance, a pacemaker can sense a heart rate of a patient, determinewhether the heart is beating too fast or too slow, and transmitelectrical stimulation to the heart to speed up or slow down differentchambers of the heart. An implantable cardioverter-defibrillator cansense a heart rate of a patient, detect a dysrhythmia, and transmit anelectrical shock to the patient.

Traditionally, cardiac monitors, pacemakers, and implantablecardioverter-defibrillators include a housing containing electricalcircuitry. A proximal end of a lead is connected to the housing and adistal end of the lead is positioned in or on the heart. The distal endof the lead contains electrodes that can receive and transmit signals.Implantable medical devices such as cardiac monitors, pacemakers, andimplantable cardioverter-defibrillators typically require invasivesurgeries to implant the medical device in the body.

SUMMARY

A subcutaneously implantable device includes a housing, a clip attachedto a top side of the housing, and an electrode. The clip is configuredto anchor the device to a muscle, a bone, and/or a first tissue. Theelectrode is configured to contact an organ, a nerve, the first tissue,and/or a second tissue. Circuitry in the housing is in electricalcommunication with the electrode and is configured to sense anelectrical signal from the organ, the nerve, the first tissue, and/orthe second tissue through the electrode; deliver electrical stimulationto the organ, the nerve, the first tissue, and/or the second tissuethrough the electrode; and/or deliver a signal to a drug pump to providea targeted or systemic therapeutic drug to the organ, the nerve, thefirst tissue, and/or the second tissue.

A subcutaneously implantable device includes a housing, a clip attachedto a top side of the housing, a prong with a proximal end attached tothe housing and a distal end extending away from the housing that, andan electrode. The clip is configured to anchor the device to a muscle, abone, and/or a first tissue. The prong is configured to contact anorgan, a nerve, and/or a second tissue. The electrode is configured tocontact the organ, the nerve, the first tissue, and/or the secondtissue. Circuitry in the housing is in electrical communication with theelectrode that is configured to sense an electrical signal from theorgan, the nerve, the first tissue, and/or the second tissue through theelectrode; deliver electrical stimulation to the organ, the nerve, thefirst tissue, and/or the second tissue through the electrode; and/ordeliver a signal to a drug pump to provide a targeted or systemictherapeutic drug to the organ, the nerve, the first tissue, and/or thesecond tissue.

BRIEF DESCRIPTION OF THE DRAWINGS Subcutaneous Device 100

FIG. 1 is a perspective view of a first embodiment of a subcutaneousdevice.

FIG. 2 is a side view of the first embodiment of the subcutaneous deviceanchored to a structural body component.

FIG. 3A is a side view of a housing of the first embodiment of thesubcutaneous device.

FIG. 3B is a top view of the housing of the first embodiment of thesubcutaneous device.

FIG. 3C is a bottom view of the housing of the first embodiment of thesubcutaneous device.

FIG. 3D is a back end view of the housing of the first embodiment of thesubcutaneous device.

FIG. 3E is a cross-sectional view of the housing of the first embodimentof the subcutaneous device, taken along line 3E-3E of FIG. 3D.

FIG. 4A is a top view of a clip of the first embodiment of thesubcutaneous device.

FIG. 4B is a bottom view of the clip of the first embodiment of thesubcutaneous device.

FIG. 4C is a side view of the clip of the first embodiment of thesubcutaneous device.

FIG. 4D is a front view of the clip of the first embodiment of thesubcutaneous device.

FIG. 4E is a back view of the clip of the first embodiment of thesubcutaneous device.

FIG. 5A is a side view of a prong of the first embodiment of thesubcutaneous device.

FIG. 5B is a top view of the prong of the first embodiment of thesubcutaneous device.

FIG. 6A is a side view of the first embodiment of the subcutaneousdevice.

FIG. 6B is a top view of the first embodiment of the subcutaneousdevice.

FIG. 6C is a bottom view of the first embodiment of the subcutaneousdevice.

FIG. 6D is a back view of the first embodiment of the subcutaneousdevice.

FIG. 6E is a front view of the first embodiment of the subcutaneousdevice.

FIG. 7 is a functional block diagram of the first embodiment of thesubcutaneous device.

FIG. 8 is a perspective view of the first embodiment of the subcutaneousdevice positioned on a xiphoid process and a sternum.

FIG. 9A is a perspective view of the first embodiment of thesubcutaneous device positioned on the xiphoid process and the sternumand showing a positioning of a prong on a heart.

FIG. 9B is a front cut away view of the first embodiment of thesubcutaneous device positioned on the xiphoid process and the sternumand showing a positioning of the prong on the heart.

FIG. 9C is a perspective cut away view of the first embodiment of thesubcutaneous device positioned on the xiphoid process and the sternumand showing a positioning of the prong on the heart.

Surgical Instrument 200

FIG. 10A is a perspective view of a surgical instrument in a firstposition.

FIG. 10B is a cross-sectional view of the surgical instrument in thefirst position.

FIG. 11A is a perspective view of a body of the surgical instrument.

FIG. 11B is a side view of the body of the surgical instrument.

FIG. 11C is a bottom view of the body of the surgical instrument.

FIG. 11D is a front view of the body of the surgical instrument.

FIG. 12A is a perspective view of a slider of the surgical instrument.

FIG. 12B is a front view of the slider of the surgical instrument.

FIG. 12C is a side view of the slider of the surgical instrument.

FIG. 12D is a bottom view of the slider of the surgical instrument.

FIG. 13A is a perspective view of a blade of the surgical instrument.

FIG. 13B is a side view of the blade of the surgical instrument.

FIG. 14A is a perspective view of the surgical instrument in a secondposition.

FIG. 14B is a cross-sectional view of the surgical instrument in asecond position.

Method 300

FIG. 15 is a flow chart showing the method for implanting the firstembodiment of the subcutaneous device using the surgical instrument.

FIG. 16A is a perspective view of the first embodiment of thesubcutaneous device in a first position in the surgical instrument.

FIG. 16B is a cross-sectional view of the first embodiment of thesubcutaneous device in the first position in the surgical instrument.

FIG. 17A is a perspective view of the first embodiment of thesubcutaneous device in a second position in the surgical instrument asthe subcutaneous device is being implanted.

FIG. 17B is a cross-sectional view of the first embodiment of thesubcutaneous device in the second position in the surgical instrument asthe subcutaneous device is being implanted.

FIG. 17C is a cross-sectional view of the first embodiment of thesubcutaneous device in the second position in the surgical instrument asthe subcutaneous device is being implanted.

FIG. 18A is a perspective view of the first embodiment of thesubcutaneous device in a third position in the surgical instrument asthe subcutaneous device is being implanted.

FIG. 18B is a cross-sectional view of the first embodiment of thesubcutaneous device in the third position in the surgical instrument asthe subcutaneous device is being implanted.

FIG. 19 is a perspective view of the first embodiment of thesubcutaneous device after it has been deployed from the surgicalinstrument.

Subcutaneous Device 400

FIG. 20 is a perspective view of a second embodiment of a subcutaneousdevice.

Subcutaneous Device 500

FIG. 21A is a perspective view of a third embodiment of a subcutaneousdevice.

FIG. 21B is a side view of the third embodiment of the subcutaneousdevice.

Subcutaneous Device 600

FIG. 22A is a perspective view of a fourth embodiment of a subcutaneousdevice.

FIG. 22B is a top view of the fourth embodiment of the subcutaneousdevice.

FIG. 22C is a bottom view of the fourth embodiment of the subcutaneousdevice.

FIG. 22D is a side view of the fourth embodiment of the subcutaneousdevice.

FIG. 22E is a back view of the fourth embodiment of the subcutaneousdevice.

FIG. 23A is a perspective view of the fourth embodiment of thesubcutaneous device positioned on a xiphoid process and a sternum andshowing a positioning of prongs on lungs.

FIG. 23B is a front view of the fourth embodiment of the subcutaneousdevice positioned on the xiphoid process and the sternum and showing apositioning of the prongs on the lungs.

FIG. 23C is a side view of the fourth embodiment of the subcutaneousdevice positioned on the xiphoid process and the sternum and showing apositioning of the prongs on the lungs.

Subcutaneous Device 700

FIG. 24A is a top view of a fifth embodiment of a subcutaneous device.

FIG. 24B is a bottom view of the fifth embodiment of the subcutaneousdevice.

FIG. 24C is a side view of the fifth embodiment of the subcutaneousdevice.

FIG. 24D is a front view of the fifth embodiment of the subcutaneousdevice.

FIG. 25A is a front view of the fifth embodiment of the subcutaneousdevice positioned on a xiphoid process and a sternum and showing apositioning of prongs around a heart.

FIG. 25B is a perspective view of the fifth embodiment of thesubcutaneous device positioned on the xiphoid process and the sternumand showing a positioning of the prongs around the heart.

Subcutaneous Device 800

FIG. 26 is a perspective view of a sixth embodiment of a subcutaneousdevice.

Subcutaneous Device 900

FIG. 27 is a perspective view of a seventh embodiment of a subcutaneousdevice.

FIG. 28 is a cut-away perspective view of the seventh embodiment of thesubcutaneous device positioned on a xiphoid process and a sternum andshowing a positioning of prongs on a heart.

Subcutaneous Device 1000

FIG. 29 is a perspective view of an eighth embodiment of a subcutaneousdevice.

Subcutaneous Device 1100

FIG. 30 is a perspective view of a ninth embodiment of a subcutaneousdevice.

Subcutaneous Device 1200

FIG. 31A is a perspective view of a tenth embodiment of a subcutaneousdevice.

FIG. 31B is a side view of the tenth embodiment of the subcutaneousdevice.

FIG. 31C is a top view of the tenth embodiment of the subcutaneousdevice.

FIG. 31D is a front view of the tenth embodiment of the subcutaneousdevice.

FIG. 31E is a back view of the tenth embodiment of the subcutaneousdevice.

FIG. 32A is a cut-away perspective view of the tenth embodiment of thesubcutaneous device positioned on a xiphoid process and a sternum andshowing a positioning of prongs on a heart.

FIG. 32B is a cut-away front view of the tenth embodiment of thesubcutaneous device positioned on the xiphoid process and the sternumand showing a positioning of the prongs on the heart.

FIG. 32C is a cut-away front view of the tenth embodiment of thesubcutaneous device positioned on the xiphoid process and the sternumand showing a positioning of the prongs on the heart.

Subcutaneous Device 1300

FIG. 33 is a perspective view of an eleventh embodiment of asubcutaneous device.

Subcutaneous Device 1400

FIG. 34A is a perspective view of a twelfth embodiment of a subcutaneousdevice.

FIG. 34B is a perspective view of the twelfth embodiment of thesubcutaneous device.

FIG. 34C is a side view of the twelfth embodiment of the subcutaneousdevice.

Subcutaneous Device 1500

FIG. 35A is a perspective view of a thirteenth embodiment of asubcutaneous device.

FIG. 35B is a perspective view of the thirteenth embodiment of thesubcutaneous device.

FIG. 35C is a bottom view of the thirteenth embodiment of thesubcutaneous device.

FIG. 35D is a side view of the thirteenth embodiment of the subcutaneousdevice.

FIG. 35E is a back view of the thirteenth embodiment of the subcutaneousdevice.

FIG. 35F is a front view of the thirteenth embodiment of thesubcutaneous device.

FIG. 36A is a schematic diagram of the thirteenth embodiment of thesubcutaneous device.

FIG. 36B is a sectional diagram illustrating portions of the thirteenthembodiment of the subcutaneous device from the side.

FIG. 36C is a sectional diagram illustrating portions of the thirteenthembodiment of the subcutaneous device from the bottom.

FIG. 37 is a perspective view of the thirteenth embodiment of thesubcutaneous device positioned on a xiphoid process and a sternum.

DETAILED DESCRIPTION

In general, the present disclosure relates to a subcutaneous device thatcan be injected into a patient for monitoring, diagnostic, andtherapeutic purposes. The subcutaneous device includes a housing thatcontains the electrical circuitry of the subcutaneous device, a clip ona top side of the housing, and one or more prongs extending away fromthe housing. The clip is configured to attach and anchor thesubcutaneous device onto a muscle, a bone, or tissue. The prong extendsaway from the housing and a distal end of the prong comes into contactwith an organ, a nerve, or tissue remote from the subcutaneous device.

The subcutaneous device can be a monitoring device, a diagnostic device,a pacemaker, an implantable cardioverter-defibrillator, a generalorgan/nerve/tissue stimulator, and/or a drug delivery device. Amonitoring device can monitor physiological parameters of a patient. Adiagnostic device can measure physiological parameters of a patient fordiagnostic purposes. A pacemaker and an implantablecardioverter-defibrillator can sense a patient's heart rate and providea therapeutic electrical stimulation to the patient's heart if anabnormality is detected. A pacemaker will provide an electricalstimulation to the heart in response to an arrhythmia, such asbradycardia, tachycardia, atrial flutter, and atrial fibrillation. Theelectrical stimulation provided by a pacemaker will contract the heartmuscles to regulate the heart rate of the patient. An implantablecardioverter-defibrillator will provide an electrical stimulation to theheart in response to ventricular fibrillation and ventriculartachycardia, both of which can lead to sudden cardiac death. Animplantable cardioverter-defibrillator will provide cardioversion ordefibrillation to the patient's heart. Cardioversion includes providingan electrical stimulation to the heart at a specific moment that is insynchrony with the cardiac cycle to restore the patient's heart rate.Cardioversion can be used to restore the patient's heart rate whenventricular tachycardia is detected. If ventricular fibrillation isdetected, defibrillation is needed. Defibrillation includes providing alarge electrical stimulation to the heart at an appropriate moment inthe cardiac cycle to restore the patient's heart rate. An implantablecardioverter-defibrillator can also provide pacing to multiple chambersof a patient's heart. A general organ/nerve/tissue stimulator canprovide electrical stimulation to an organ, nerve, or tissue of apatient for therapeutic purposes. A drug delivery device can providetargeted or systemic therapeutic drugs to an organ, nerve, or tissue ofa patient.

The subcutaneous device described in this disclosure can, in someembodiments, be anchored to a patient's xiphoid process and/or a distalend of a patient's sternum. The xiphoid process is a process on thelower part of the sternum. At birth, the xiphoid process is acartilaginous process. The xiphoid process ossifies over time, causingit to fuse to the sternum with a fibrous joint. The subcutaneous devicecan be anchored to the xiphoid process so that the housing of thesubcutaneous device is positioned below the xiphoid process and sternum.In some patients, the xiphoid process is absent, small, narrow, orelongated. In such cases, the subcutaneous device can be attacheddirectly to the distal end of the patient's sternum. When thesubcutaneous device is anchored to the xiphoid process and/or sternum,the one or more prongs of the subcutaneous device extend into theanterior mediastinum.

Different embodiments of the subcutaneous device are described in detailbelow. The different embodiments of the subcutaneous device can include:a single prong cardiac monitoring device, a multi-prong cardiacmonitoring device, a pulmonary monitoring device, a single chamberpacemaker, a dual chamber pacemaker, a triple chamber pacemaker, anatrial defibrillator, a single-vector ventricular defibrillator, amulti-vector ventricular defibrillator, and an implantable drug pumpand/or drug delivery device. These embodiments are included as examplesand are not intended to be limiting. The subcutaneous device can haveany suitable design and can be used for any suitable purpose in otherembodiments. The features of each embodiment may be combined and/orsubstituted with features of any other embodiment, unless explicitlydisclosed otherwise. Further, many of the embodiments can be used formultiple purposes. For example, a defibrillator device can also be usedfor monitoring and pacing. A surgical instrument and a method forimplanting the subcutaneous device into a body of a patient is alsodescribed.

Subcutaneous Device 100

FIG. 1 is a perspective view of subcutaneous device 100. FIG. 2 is aside view of subcutaneous device 100 anchored to structural bodycomponent A. Subcutaneous device 100 includes housing 102, clip 104, andprong 106. FIG. 2 shows structural body component A and remote bodycomponent B.

Subcutaneous device 100 is a medical device that is anchored tostructural body component A. Structural body component A may be amuscle, a bone, or a tissue of a patient. Subcutaneous device 100 can bea monitoring device, a diagnostic device, a therapeutic device, or anycombination thereof. For example, subcutaneous device 100 can be apacemaker device that is capable of monitoring a patient's heart rate,diagnosing an arrhythmia of the patient's heart, and providingtherapeutic electrical stimulation to the patient's heart. Subcutaneousdevice 100 includes housing 102. Housing 102 can contain a power source,a controller, a memory, a transceiver, sensors, sensing circuitry,therapeutic circuitry, and/or any other component of the medical device.Housing 102 can also include one or more electrodes that are capable ofsensing an electrical activity or physiological parameter of tissuesurrounding housing 102 and/or provide therapeutic electricalstimulation to the tissue surrounding housing 102.

Clip 104 is attached to housing 102. Clip 104 is configured to anchorsubcutaneous device 100 to structural body component A. Clip 104 willexpand as it is advanced around structural body component A. Clip 104can be a passive clip or an active clip. A passive clip only uses thestiffness of clamping components to attach to the bone, the muscle, orthe tissue. This stiffness can be the result of design or activecrimping during the implant procedure. An active clip may additionallyuse an active fixation method such as sutures, tines, pins, or screws tosecure the clip to the bone, the muscle, or the tissue. In theembodiment shown in FIGS. 1-2, clip 104 has a spring bias that will puttension on structural body component A when it is expanded and fit ontostructural body component A. The spring bias of clip 104 will anchorsubcutaneous device 100 to structural body component A. Clip 104 caninclude one or more electrodes that are capable of sensing an electricalactivity or physiological parameter of tissue surrounding clip 104and/or provide therapeutic electrical stimulation to the tissuesurrounding clip 104.

Prong 106 is connected to and extends away from housing 102 ofsubcutaneous device 100. Prong 106 is configured to contact remote bodycomponent B that is positioned away from structural body component A.Remote body component B may be an organ, a nerve, or tissue of thepatient. For example, remote body component B can include a heart, alung, or any other suitable organ in the body. Prong 106 includes one ormore electrodes that are capable of sensing an electrical activity orphysiological parameter of remote body component B and/or providingtherapeutic electrical stimulation to remote body component B.

In one example, subcutaneous device 100 can be a pacemaker and the oneor more electrodes on prong 106 of subcutaneous device 100 can sense theelectrical activity of a heart. The sensed electrical activity can betransmitted to sensing circuitry and a controller in housing 102 ofsubcutaneous device 100. The controller can determine the heart rate ofthe patient and can detect whether an arrhythmia is present. If anarrhythmia is detected, the controller can send instructions totherapeutic circuitry to provide a therapeutic electrical stimulation tothe heart. In this manner, subcutaneous device 100 functions as amonitoring device, a diagnostic device, and a therapeutic device.

Subcutaneous device 100 will be discussed in greater detail in relationto FIGS. 3A-9 below. Subcutaneous device 100 will be discussed as apacemaker that can be used for monitoring, diagnostics, and therapeuticsin the discussion of FIGS. 3A-9 below. Subcutaneous device 100 can alsobe used only for monitoring, diagnostics, or a combination of the two inalternate embodiments. Further, subcutaneous device 100 can be aunipolar pacemaker or a bipolar pacemaker.

FIG. 3A is a side view of housing 102 of subcutaneous device 100. FIG.3B is a top view of housing 102 of subcutaneous device 100. FIG. 3C is abottom view of housing 102 of subcutaneous device 100. FIG. 3D is a backend view of housing 102 of subcutaneous device 100. FIG. 3E is across-sectional view of housing 102 of subcutaneous device 100. Housing102 includes first side 110, second side 112, top side 114, bottom side116, front end 118, back end 120, curved surface 122, recess 124, port126, channel 128, first guide 130, second guide 132, electrode 134, andelectrode 136.

Housing 102 includes first side 110, second side 112, top side 114,bottom side 116, front end 118, and back end 120. First side 110 isopposite of second side 112; top side 114 is opposite of bottom side116; and front end 118 is opposite of back end 120. Housing 102 issubstantially rectangular-shaped in the embodiment shown. In alternateembodiments, housing 102 can be shaped as a cone, frustum, or cylinder.Housing 102 can be made out of stainless steel, titanium, nitinol,epoxy, silicone, polyurethane with metallic reinforcements, or any othermaterial that is suitable for non-porous implants. Housing 102 can alsoinclude an exterior coating. Curved surface 122 is positioned on topside 114 of housing 102 adjacent front end 118 of housing 102. Curvedsurface 122 creates a tapered front end 118 of housing 102 ofsubcutaneous device 100. In an alternate embodiment, front end 118 ofhousing 102 can be wedge shaped. The tapered front end 118 of housing102 helps front end 118 of housing 102 to push through tissue in a bodyof a patient to permit easier advancement of subcutaneous device 100during the implantation or injection process.

Housing 102 includes recess 124 on top side 114. Recess 124 is a groovethat extends into housing 102 on top side 114 of housing 102 adjacentback end 120 of housing 102. A portion of clip 104 of subcutaneousdevice 100 (shown in FIGS. 1-2) is positioned in recess 124 to attachclip 104 to housing 102. In an alternate embodiment, recess 124 may notbe included on housing 102 and clip 104 can be welded to top side 114 ofhousing 102 or connected to a header. Housing 102 further includes port126 on back end 120. Port 126 is a bore that extends into housing 102 onback end 120 of housing 102. A proximal end of prong 106 of subcutaneousdevice 100 (shown in FIGS. 1-2) is positioned in port 126 to attachprong 106 to housing 102. In an alternate embodiment, port 126 can bepositioned in a header. Housing 102 also includes channel 128 on backend 120 and bottom side 116. Channel 128 is a groove that extends intohousing 102 on back end 120 and bottom side 116 of housing 102. Channel128 is configured to receive a portion of prong 106 of subcutaneousdevice 100 (shown in FIGS. 1-2) when subcutaneous device 100 is in astowed position.

Housing 102 also includes first guide 130 on first side 110 and secondguide 132 on second side 112. First guide 130 is a ridge that extendsout from first side 110 of housing 102. Second guide 132 is a ridge thatextends out from second side 112 of housing 102. First guide 130 andsecond guide 132 are configured to guide housing 102 of subcutaneousdevice 100 through a surgical instrument used to implant subcutaneousdevice 100 in a patient.

Housing 102 further includes electrode 134 on front end 118 of housing102 and electrode 136 on back end 120 of housing 102. In the embodimentshown in FIGS. 3A-3E, there are two electrodes 134 and 136 positioned onhousing 102. In alternate embodiments, any number of electrodes can bepositioned on housing 102 or housing 102 can include no electrodes.Electrode 134 and electrode 136 are positioned to sense an electricalactivity or physiological parameter of the tissue surrounding housing102. Electrode 134 and electrode 136 can also provide therapeuticelectrical stimulation to the tissue surrounding housing 102.

FIG. 4A is a top view of clip 104 of subcutaneous device 100. FIG. 4B isa bottom view of clip 104 of subcutaneous device 100. FIG. 4C is a sideview of clip 104 of subcutaneous device 100. FIG. 4D is a front view ofclip 104 of subcutaneous device 100. FIG. 4E is a back view of clip 104of subcutaneous device 100. Clip 104 includes top portion 140, bottomportion 142, spring portion 144, tip 146, openings 148, slot 150, andelectrode 152.

Clip 104 includes top portion 140, bottom portion 142, and springportion 144. Top portion 140 is a flat portion that forms a top of clip104, and bottom portion 142 is a flat portion that forms a bottom ofclip 104. Bottom portion 142 is configured to be attached to housing 102of subcutaneous device 100 (shown in FIGS. 1-3E). Spring portion 144 isa curved portion positioned on a back end of clip 104 that extendsbetween and connects top portion 140 to bottom portion 142. Clip 104 canbe made out of stainless steel, titanium, nitinol, epoxy, silicone,polyurethane with metallic reinforcements, or any other material that issuitable for non-porous implants.

Top portion 140 of clip 104 includes tip 146 adjacent to a front end ofclip 104. Top portion 140 tapers from a middle of top portion 140 to tip146. The taper of tip 146 of top portion 140 of clip 104 helps clip 104push through tissue when clip 104 is being anchored to a muscle, a bone,or a tissue of a patient. A surgeon does not have to cut a path throughthe tissue of the patient, as the taper of tip 146 of top portion 140 ofclip 104 will create a path through the tissue.

Top portion 140 further includes openings 148. Openings 148 extendthrough top portion 140. There are two openings 148 in top portion 140in the embodiment shown in FIGS. 3A-3E, but there could be any number ofopenings 148 in alternate embodiments. Openings 148 are configured toallow clip 104 to be sutured to a muscle, a bone, or a tissue in apatient to secure subcutaneous device 100 to the muscle, the bone, orthe tissue. Further, openings 148 can receive additional fixationmechanisms, such as tines, pins, or screws, to secure subcutaneousdevice 100 to the muscle, the bone, or the tissue. These additionalfixation mechanisms can be made from bioabsorbable materials. Clip 104also includes slot 150. Slot 150 is an opening that extends throughspring portion 144 of clip 104. Slot 150 is configured to receive ablade of a surgical instrument that is used to implant subcutaneousdevice 100 in a patient.

Spring portion 144 acts as a spring for clip 104 and is under tension.Top portion 140 acts as a tension arm and the forces from spring portion144 translate to and push down on top portion 140. In its natural state,a spring bias of spring portion 144 forces tip 146 of top portion 140towards bottom portion 142 of clip 104. Tip 146 of top portion 140 canbe lifted up and clip 104 can be positioned on a muscle, a bone, ortissue of a patient. When clip 104 is positioned on a muscle, a bone, ortissue of a patient, the tension in spring portion 144 will force topportion 140 down onto the muscle, the bone, or the tissue. This tensionwill anchor clip 104 to the muscle, the bone, or the tissue. Additionalfixation mechanisms, such as tines, pins, or screws can also be used toanchor clip 104 to the bone, the muscle, or the tissue.

Clip 104 also includes electrode 152 on top surface 140 of clip 104. Inthe embodiment shown in FIGS. 4A-4E, there is a single electrode 152positioned on clip 104. In alternate embodiments, any number ofelectrodes can be positioned on clip 104 or clip 104 can include noelectrodes. Electrode 152 is positioned on top surface 140 of clip 104to sense an electrical activity or physiological parameter of the tissuesurrounding clip 104. Electrode 152 can also provide therapeuticelectrical stimulation to the tissue surrounding clip 104.

FIG. 5A is a side view of prong 106 of subcutaneous device 100. FIG. 5Bis a top view of prong 106 of subcutaneous device 100. Prong 106includes proximal end 160, distal end 162, base portion 164, springportion 166, arm portion 168, contact portion 170, and electrode 172.

Prong 106 includes proximal end 160 and distal end 162 that is oppositeof proximal end 160. Proximal end 160 of prong 106 may have strainrelief or additional material to support movement. Prong 106 includesbase portion 164, spring portion 166, arm portion 168, and contactportion 170. A first end of base portion 164 is aligned with proximalend 160 of prong 106, and a second end of base portion 164 is connectedto a first end of spring portion 166. Base portion 164 is a straightportion that positioned in port 126 of housing 102 (shown in FIGS.3D-3E). The first end of spring portion 166 is connected to the secondend of base portion 164, and a second end of spring portion 166 isconnected to a first end of arm portion 168. The first end of armportion 168 is connected to the second end of spring portion 166, and asecond end of arm portion 168 is connected to a first end of contactportion 170. Arm portion 168 is a straight portion. The first end ofcontact portion 170 is connected to the second end of arm portion 168,and a second end of contact portion 170 is aligned with distal end 162of prong 106. Contact portion 170 can be positioned to contact remotebody component B (shown in FIG. 2). Spring portion 166 acts as a springfor prong 106 and is under tension. Arm portion 168 acts as a tensionarm and the forces from spring portion 166 translate to and push down onarm portion 168. In its natural state, a spring bias of spring portion166 forces distal end 162 of prong 106 away from bottom side 116 ofhousing 102.

Prong 106 further includes electrode 172. Electrode 172 is shown asbeing on distal end 162 in the embodiment shown in FIGS. 5A-5B. Inalternate embodiments, electrode 172 can be positioned at any point oncontact portion 170 and can have any shape and configuration. Further,prong 106 is shown as having a single electrode 172 in the embodimentshown in FIGS. 5A-5B. Prong 106 can have any number of electrodes inalternate embodiments. Electrode 172 is positioned on distal end 162 ofprong 106 to sense an electrical activity or physiological status ofremote body component B. Electrode 172 can also provide therapeuticelectrical stimulation to remote body component B.

Prong 106 is made of a stiff material so that it is capable of pushingthrough tissue in the body when subcutaneous device 100 in implantedinto a patient. Prong 106 can be made out of nickel titanium, also knownas Nitinol. Nitinol is a shape memory alloy with superelasticity,allowing prong 106 to go back to its original shape and position ifprong 106 is deformed as subcutaneous device 100 is implanted into apatient. Prong 106 can also be made out of silicone, polyurethane,stainless steel, titanium, epoxy, polyurethane with metallicreinforcements, or any other material that is suitable for non-porousimplants. As an example, prong 106 can be made out of a composite madeof polyurethane and silicone and reinforced with metal to provide springstiffness.

Spring portion 166 of prong 106 allows prong 106 to be flexible once itis positioned in the body. For example, if remote body component B is aheart of a patient and contact portion 170 of prong 106 is positionedagainst the heart, spring portion 166 of prong 106 allows prong 106 tomove with up and down as the heart beats. This ensures that prong 106does not puncture or damage the heart when contact portion 170 of prong106 is in contact with the heart. Distal end 162 of prong 106 has arounded shape to prevent prong 106 from puncturing or damaging the heartwhen contact portion 170 of prong 106 is in contact with the heart. Theoverall axial stiffness of prong 106 can be adjusted so that prong 106gently presses against the heart and moves up and down in contact withthe heart as the heart beats, but is not stiff or sharp enough to pierceor tear the pericardial or epicardial tissue.

FIG. 6A is a side view of subcutaneous device 100. FIG. 6B is a top viewof subcutaneous device 100. FIG. 6C is a bottom view of subcutaneousdevice 100. FIG. 6D is a back view of subcutaneous device 100. FIG. 6Eis a front view of subcutaneous device 100. Subcutaneous device 100includes housing 102, clip 104, and prong 106. Housing 102 includesfirst side 110, second side 112, top side 114, bottom side 116, frontend 118, back end 120, curved surface 122, recess 124, port 126, channel128, first guide 130, second guide 132, electrode 134, and electrode136. Clip 104 includes top portion 140, bottom portion 142, springportion 144, tip 146, openings 148, slot 150, and electrode 152. Prong106 includes proximal end 160, distal end 162, base portion 164, springportion 166, arm portion 168, contact portion 170, and electrode 172.

Subcutaneous device 100 includes housing 102, clip 104, and prong 106.Housing 102 is described in detail in reference to FIGS. 3A-3E above.Clip 104 is described in detail in reference to FIGS. 4A-4E above. Prong106 is described in detail in reference to FIGS. 6A-6B above.

Clip 104 is connected to top side 114 of housing 102 of subcutaneousdevice 100. Recess 124 of housing 102 is shaped to fit bottom portion142 of clip 104. Bottom portion 142 is positioned in and connected torecess 124 of housing 102, for example by welding. Spring portion 144 ofclip 104 is aligned with back side 120 of housing 102. Top portion 140of clip 104 extends along top side 114 of housing 102. The spring biasin clip 104 will force tip 146 of clip 104 towards housing 102. Clip 104can be expanded by lifting up tip 146 of clip 104 to position clip 104on a bone, a muscle, or a tissue of a patient. When clip 104 ispositioned on a muscle, a bone, or a tissue of a patient, the tension inspring portion 144 will force top portion 140 of clip 104 down onto themuscle, the bone, or the tissue. This tension will anchor clip 104, andthus subcutaneous device 100, to the muscle, the bone, or the tissue.

Prong 106 is connected to back side 120 of housing 102 of subcutaneousdevice 100. Port 126 of housing 102 is shaped to fit base portion 164 ofprong 106. Base portion 164 of prong 106 is positioned in port 126 ofhousing 102. Base portion 164 of prong 106 is electrically connected tothe internal components of housing 102, for example with a feedthrough.Base portion 164 of prong 106 is also hermetically sealed in port 126 ofhousing 102. Spring portion 166 of prong 106 curves around back side 120of housing 102 and arm portion 168 extends underneath bottom side 116 ofhousing 102. Arm portion 168 extends past front end 118 of housing 102so that contact portion 170 is positioned outwards from front end 118 ofhousing 102. In alternate embodiments, prong 106 can have differentshapes and lengths. Further, prong 106 can extend from housing 102 inany direction.

Subcutaneous device 100 is shown in a deployed position in FIGS. 6A-6E.Subcutaneous device 100 will be in the deployed position whensubcutaneous device 100 is implanted in a patient. In the deployedposition, prong 106 only contacts housing 102 at base portion 164.Subcutaneous device also has a stowed position. Subcutaneous device 100is in the stowed position when subcutaneous device 100 is loaded in asurgical instrument prior to delivery to the patient. In the stowedposition, arm portion 168 of prong 106 is positioned in channel 128 ofhousing 102. Channel 128 of housing 102 holds arm portion 168 of prong106 in a centered position with respect to housing 102 when subcutaneousdevice 100 is in a stowed position. When subcutaneous device isimplanted in a patient, subcutaneous device 100 will deploy. The tensionof spring portion 166 of prong 106 will force arm portion 168 outwardsaway from channel 128 of housing 102.

Subcutaneous device 100 can function as a pacemaker. Prong 106 can beshaped so that contact portion 170 of prong 106 contacts the rightventricle, left ventricle, right atrium, or left atrium of the heart.Subcutaneous device 100 can function as a unipolar pacemaker, utilizingelectrode 172 on prong 106 and one of electrode 134 or electrode 136 onhousing 102 or electrode 152 on clip 104. Further, subcutaneous device100 can function as a bipolar pacemaker, utilizing electrode 172 onprong 106 and a second electrode also positioned on prong 106.

FIG. 7 is a functional block diagram of subcutaneous device 100.Subcutaneous device 100 includes housing 102, sensing circuitry 180,controller 182, memory 184, therapy circuitry 186, electrode(s) 188,sensor(s) 190, transceiver 192, and power source 194.

Housing 102 contains sensing circuitry 180, controller 182, memory 184,and therapy circuitry 186. Sensing circuitry 180 receives electricalsignals from the heart and communicates the electrical signals tocontroller 182. Controller 182 analyzes the electrical signals andexecutes instructions stored in memory 184 to determine if there is anarrhythmia in the patient's heart rate. If controller 182 determinesthat there is an arrhythmia, controller 182 will send instructions totherapy circuitry 186 to send electrical stimulation to the heart toregulate the heart rate of the patient. Sensing circuitry 180 andtherapy circuitry 186 are both in communication with electrode(s) 188.Electrode(s) 188 can be positioned in housing 102, clip 104, and/orprong 106 and are in contact with an organ, a nerve, or a tissue whensubcutaneous device 100 is implanted in a patient. Electrode(s) 188sense electrical signals from the organ, the nerve, or the tissue andprovide electrical stimulation to the heart.

Controller 182 is also in communication with sensor(s) 190 throughsensing circuitry 180. Sensor(s) 190 can be positioned in housing 102and/or prong 106. Sensor(s) 190 can be used with controller 182 todetermine physiological parameters of the patient. Controller 182 isfurther in communication with transceiver 192 that is positioned inhousing 102. Transceiver 192 can receive information and instructionsfrom outside of subcutaneous device 100 and send information gathered insubcutaneous device 100 outside of subcutaneous device 100. Power source194 is also positioned in housing 102 and provides power to thecomponents in housing 102, clip 104, and prong 106, as needed. Powersource 194 can be a battery that provides power to the components inhousing 102.

Sensing circuitry 180 is electrically coupled to electrode(s) 188 viaconductors extending through prong 106 and into housing 102. Sensingcircuitry 180 is configured to receive a sensing vector formed byelectrode(s) 188 and translate the sensing vector into an electricalsignal that can be communicated to controller 182. Sensing circuitry 180can be any suitable circuitry, including electrodes (including positiveand negative ends), analog circuitry, analog to digital converters,amps, microcontrollers, and power sources.

Controller 182 is configured to implement functionality and/or processinstructions for execution within subcutaneous device 100. Controller182 can process instructions stored in memory 184. Examples ofcontroller 182 can include any one or more of a microcontroller, amicroprocessor, a digital signal processor (DSP), an applicationspecific integrated circuit (ASIC), a field-programmable gate array(FPGA), or other equivalent discrete or integrated logic circuitry.

Memory 184 can be configured to store information within subcutaneousdevice 100 during operation. Memory 184, in some examples, is describedas computer-readable storage media. In some examples, acomputer-readable storage medium can include a non-transitory medium.The term “non-transitory” can indicate that the storage medium is notembodied in a carrier wave or a propagated signal. In certain examples,a non-transitory storage medium can store data that can, over time,change (e.g., in RAM or cache). In some examples, memory 184 is atemporary memory, meaning that a primary purpose of memory 184 is notlong-term storage. Memory 184, in some examples, is described asvolatile memory, meaning that memory 184 does not maintain storedcontents when power to subcutaneous device 100 is turned off. Examplesof volatile memories can include random access memories (RAM), dynamicrandom access memories (DRAM), static random access memories (SRAM), andother forms of volatile memories. In some examples, memory 184 is usedto store program instructions for execution by controller 182. Memory184, in one example, is used by software or applications running onsubcutaneous device 100 to temporarily store information during programexecution.

Memory 184, in some examples, also includes one or morecomputer-readable storage media. Memory 184 can be configured to storelarger amounts of information than volatile memory. Memory 184 canfurther be configured for long-term storage of information. In someexamples, memory 184 can include non-volatile storage elements. Examplesof such non-volatile storage elements can include magnetic hard discs,optical discs, floppy discs, flash memories, or forms of electricallyprogrammable memories (EPROM) or electrically erasable and programmable(EEPROM) memories.

Controller 182 can receive electrical signals from sensing circuitry180, analyze the electrical signals, and execute instructions stored inmemory 184 to determine whether an arrhythmia is present in the heartrate of a patient. If an arrhythmia is detected, controller 182 can sendinstructions to therapy circuitry 186 to deliver an electricalstimulation to the heart via electrode(s) 188.

Therapy circuitry 186 is electrically coupled to electrode(s) 188 viaconductors extending through prong 106 and into housing 102. Therapycircuitry 186 is configured to deliver an electrical stimulation to theheart via electrode(s) 188. Therapy circuitry 186 will include acapacitor to generate the electrical stimulation. Therapy circuitry 180can be any suitable circuitry, including microcontroller, power sources,capacitors, and digital to analog converters.

Controller 182 can also receive information from sensor(s) 190.Sensor(s) 190 can include any suitable sensor, including, but notlimited to, temperature sensors, accelerometers, pressure sensors,proximity sensors, infrared sensors, optical sensors, and ultrasonicsensors. The information from sensor(s) 190 allows subcutaneous device100 to sense physiological parameters of a patient. For example, thedata from the sensors can be used to calculate heart rate, heart rhythm,respiration rate, respiration waveform, activity, movement, posture,oxygen saturation, photoplethysmogram (PPG), blood pressure, core bodytemperature, pulmonary edema, and pulmonary wetness. The accelerometercan also be used for rate responsive pacing.

Subcutaneous device 100 also includes transceiver 192. Subcutaneousdevice 100, in one example, utilizes transceiver 192 to communicate withexternal devices via wireless communication. Subcutaneous device 100, ina second example, utilizes transceiver 192 to communication with otherdevices implanted in the patient via wireless communication. Transceiver192 can be a network interface card, such as an Ethernet card, anoptical transceiver, a radio frequency transceiver, or any other type ofdevice that can send and receive information. Other examples of suchnetwork interfaces can include Bluetooth, 3G, 4G, WiFi radio computingdevices, Universal Serial Bus (USB), standard inductive coupling, lowfrequency medical frequency radio (MICS), ultra-wide band radio,standard audio, and ultrasonic radio. Examples of external devices thattransceiver 192 can communicate with include laptop computers, mobilephones (including smartphones), tablet computers, personal digitalassistants (PDAs), desktop computers, servers, mainframes, cloudservers, or other devices. Other devices implanted in the body caninclude other implantable medical devices, such as other pacemakers,implantable cardioversion-defibrillators, nerve stimulators, and thelike. Transceiver 192 can also be connected to an antenna.

Subcutaneous device 100 includes power source 194 positioned in housing102. Subcutaneous device 100 can also include a battery or deviceoutside of housing 102 that transmits power and data to subcutaneousdevice 100 through wireless coupling or RF. Further, power source 194can be a rechargeable battery.

The internal components of subcutaneous device 100 described above inreference to FIG. 7 is intended to be exemplary. Subcutaneous device 100can include more, less, or other suitable components. For example, whensubcutaneous device 100 is only used for diagnostics, subcutaneousdevice 100 will not include therapy circuitry 186. As a further example,subcutaneous device 100 can function as a pacemaker without sensor(s)190.

FIG. 8 is a perspective view of subcutaneous device 100 positioned onxiphoid process X and sternum S. FIG. 9A is a perspective view ofsubcutaneous device 100 positioned on xiphoid process X and sternum Sand showing a positioning of prong 104 on heart H. FIG. 9B is a frontcut away view of subcutaneous device 100 positioned on xiphoid process Xand sternum S and showing a positioning of prong 104 on heart H. FIG. 9Cis a perspective cut away view of subcutaneous device 100 positioned onxiphoid process X and sternum S and showing a positioning of prong 104on heart H. Subcutaneous device 100 includes housing 102, clip 104, andprong 106. Housing 102 includes top side 114, front end 118, and curvedsurface 122. Clip 104 includes top portion 140, spring portion 144, andopenings 148. Prong 106 includes distal end 162, spring portion 166,contact portion 170, and electrode 172. FIGS. 8-9C show xiphoid processX and sternum S. FIGS. 9A-9C further show heart H and right ventricleRV. FIG. 9B also shows ribs R.

FIGS. 8-9C show xiphoid process X and sternum S. FIG. 9B further showsxiphoid process X and sternum S in relation to ribs R. Subcutaneousdevice 100 can be anchored to xiphoid process X and sternum S of apatient. Xiphoid process X is a process extending from a lower end ofsternum S. When subcutaneous device 100 is anchored to xiphoid processX, housing 102 of subcutaneous device 100 will be partially positionedunderneath sternum S of the patient. In some patients, xiphoid process Xis absent, small, narrow, or elongated, and subcutaneous device 100 canbe attached directly to a distal end of sternum S. Subcutaneous devicewill be positioned in the anterior mediastinum of the patient when it isanchored to the xiphoid process X and sternum S. The anteriormediastinum is an area that is anterior to the pericardium, posterior tosternum S, and inferior to the thoracic plane. The anterior mediastinumincludes loose connective tissues, lymph nodes, and substernalmusculature.

When subcutaneous device 100 is deployed onto xiphoid process X andsternum S, housing 102 and prong 106 of subcutaneous device 100 willmove through the anterior mediastinum. Curved surface 122 on top side114 of housing 102 creates a tapered front end 118 of housing 102 tohelp subcutaneous device 100 push through the tissue in the anteriormediastinum. Further, prong 106 is made of a stiff material to allow itto push through the tissue in the anterior mediastinum.

Subcutaneous device 100 can be anchored to xiphoid process X and sternumS with clip 104. When clip 104 is positioned on xiphoid process X, topportion 140 of clip 104 will be positioned superior to xiphoid process Xand sternum S. Spring portion 144 of clip 104 will put tension on topportion 140 of clip 104 to push top portion 140 down onto xiphoidprocess X and sternum S. Clip 104 will hold subcutaneous device 100 inposition on xiphoid process X and sternum S. Further, openings 148 intop portion 140 of clip 104 can be used to suture clip 104 to xiphoidprocess X and sternum S, or openings 148 can receive additional fixationmechanisms, such as tines, pins, or screws. This will further anchorsubcutaneous device 100 to xiphoid process X and sternum S.

When subcutaneous device 100 is anchored to xiphoid process X andsternum S, prong 106 will extend from housing 102 and come into contactwith heart H of the patient. Specifically, contact portion 170 andelectrode 172 of prong 106 will come into contact with the pericardium.The pericardium is the fibrous sac that surrounds heart H. Electrode 172will be positioned on the portion of the pericardium that surroundsright ventricle RV of heart H. An electrical stimulation can be appliedto right ventricle RV of heart H, causing heart H to contract, bytransmitting the electrical signal from electrode 172 on distal end 162of prong 106 through the pericardium and epicardium and into themyocardium of heart H. Prong 106 can also sense electrical signals fromheart H to determine a surface ECG of heart H.

As heart H beats, it will move in a vertical and a three-dimensionalpattern. Spring portion 166 of prong 106 provides some flexibility toprong 106 to allow prong 106 to move with heart H as it beats. This willensure that prong 106 does not puncture or damage heart H.

Anchoring subcutaneous device 100 to xiphoid process X and sternum Sensures that subcutaneous device 100 will not migrate in the patient'sbody. Maintaining the position of subcutaneous device 100 in the bodyensures that prong 106 is properly positioned and will not lose contactwith heart H. Further, subcutaneous device 100 is able to accurately andreliably determine a heart rate and other physiological parameters ofthe patient, as subcutaneous device 100 will not move in the patient'sbody. For instance, the ECG morphology will not change due to movementof subcutaneous device 100 within the patient's body.

Subcutaneous device 100 can be implanted with a simple procedure wheresubcutaneous device 100 is injected onto xiphoid process X using asurgical instrument. The surgical procedure for implanting subcutaneousdevice 100 is less invasive than the surgical procedure required formore traditional pacemaker devices, as subcutaneous device is placedsubcutaneously in the body. No leads need to be positioned in thevasculature of the patient, lowering the risk of thrombosis to thepatient. A surgical instrument and a method for implanting subcutaneousdevice 100 are described in greater details below.

Injectable Tool 200

FIG. 10A is a perspective view of surgical instrument 200 in a firstposition. FIG. 10B is a cross-sectional perspective view of surgicalinstrument 200 in the first position. Surgical instrument 200 includesbody 202, slider 204, blade 206, bolt 208, and screw 210.

Surgical instrument 200 can be used to implant a medical device in apatient. In the following discussion, subcutaneous device 100 (shown inFIGS. 1-9) will be used as an example of a device that can be implantedin a patient using surgical instrument 200. However, surgical instrument200 can be used to implant any suitable medical device in a patient,including any of subcutaneous devices 400, 500, 600, 700, 800, 900,1000, 1100, 1200, 1300, 1400, and 1500 shown in FIGS. 20-37.

Surgical instrument 200 includes body 202 that can be grasped by a userto hold and maneuver surgical instrument 200. Surgical instrument 200further includes slider 204 and blade 206 that are attached to body 202.Bolt 208 extends through body 202 and slider 204 to hold slider 204 inposition in surgical instrument 200. Slider 204 is configured to deploya subcutaneous device into a body of a patient when a subcutaneousdevice is stowed in surgical instrument 200. Screw 210 extends throughblade 206 and into body 202 to mount blade 206 to body 202. Blade 206 isconfigured to extend past a front end of surgical instrument 200 and canbe used to cut through tissue prior to deploying a subcutaneous devicethat is stowed in surgical instrument 200 into a patient. In analternate embodiment, blade 206 can be a separate blade that is notconnected to surgical instrument 200.

Surgical instrument 200 in shown in a first position in FIGS. 10A-10B.In the first position, slider 204 is positioned to abut body 202 andsubcutaneous device 100 (shown in FIGS. 1-9) can be loaded into surgicalinstrument 200. Surgical instrument 200 can be used to injectsubcutaneous device 100 onto a bone, a muscle, or a tissue of a patient.In one example, surgical instrument 200 can be used to injectsubcutaneous device 100 onto a xiphoid process and a sternum of apatient.

FIG. 11A is a perspective view of body 202 of surgical instrument 200.FIG. 11B is a side view of body 202 of surgical instrument 200. FIG. 11Cis a bottom view of body 202 of surgical instrument 200. FIG. 11D is afront view of body 202 of surgical instrument 200. Body 202 includesbase 220, handle 222, upper arm 224, lower arm 226, slider slot 228,bolt aperture 230, bolt aperture 232, blade slot 234, screw aperture236, guide track 238, guide track 240, and prong track 242.

Body 202 includes base 220, handle 222, upper arm 224, and lower arm 226that are integral with one another to form body 202. Base 220 forms asupport portion in the middle of body 202. Handle 220 extends away froma back end of base 220. Handle 220 can be grasped by a user to graspbody 202 of surgical instrument 200. Upper arm 224 and lower arm 226extend away from a front end of base 220. Upper arm 224 is positioned onan upper side of base 220, and lower arm 226 is positioned on a lowerside of base 220. Body 202 can be made out of any suitable metallic orplastic material.

Upper arm 224 includes slider slot 228 that forms an opening in upperarm 224. Slider slot 228 is configured to allow slider 204 of surgicalinstrument 200 (shown in FIGS. 10A-10B) to slide through upper arm 224.Upper arm 224 further includes bolt aperture 230 that extends through afront end of upper arm 224. Bolt aperture 230 of upper arm 224 isconfigured to receive bolt 208 of surgical instrument 200 (shown inFIGS. 10A-10B). Bolt aperture 230 has a recessed portion that isconfigured to receive a head of bolt 208 so that bolt 208 is flush witha front end of body 202.

Base 210 includes bolt aperture 232 that extends into an upper end ofbase 210. Bolt aperture 232 of base 210 is configured to receive bolt208 of surgical instrument 200 (shown in FIGS. 10A-10B). Bolt aperture232 is threaded to receive threads on bolt 208. Base 210 furtherincludes blade slot 234 that extends into a middle of base 210. Bladeslot 234 of base 210 is configured to receive blade 206 of surgicalinstrument 200 (shown in FIGS. 10A-10B). Base 210 also includes screwaperture 236 extending up into base 210 from a bottom side of base 210.Screw aperture 236 is configured to receive screw 210 of surgicalinstrument 200 (shown in FIGS. 10A-10B). Blade slot 234 extends intoscrew aperture 236 so that screw 210 can extend through blade 206 tomount blade 206 to surgical instrument 200.

Lower arm 226 includes first guide track 238 and second guide track 240.First guide track 238 is a groove extending along an inner surface of afirst side of lower arm 226, and second guide track 240 is a grooveextending along an inner surface of a second side of lower arm 226.First guide track 238 and second guide track 240 are configured toreceive first guide 130 and second guide 132 of housing 102 ofsubcutaneous device 100 (shown in FIGS. 3A-3D and 6A-6E), respectively.Lower arm 226 further includes prong track 242. Prong track 242 is agroove extending along a top surface of lower arm 226. Prong track 242is configured to receive prong 106 of subcutaneous device 100.

FIG. 12A is a perspective view of slider 204 of surgical instrument 200.FIG. 12B is a front view of slider 204 of surgical instrument 200. FIG.12C is a side view of slider 204 of surgical instrument 200. FIG. 12D isa bottom view of slider 204 of surgical instrument 200. Slider 204includes base 250, knob 252, shaft 254, first guide 256, second guide258, third guide 260, fourth guide 262, bolt aperture 264, blade slot266, first shoulder 268, second shoulder 270, and device notch 272.

Slider 204 includes base 250, knob 252, and shaft 254 that are integralwith one another to form slider 204. Base 250 form a support portion inthe middle of slider 204. Knob 252 extends upwards from base 250. Knob252 can be grasped by a user to slide slider 204 within surgicalinstrument 200. Shaft 254 extends downwards from base 250.

Base 250 includes first guide 256 and second guide 258 on a bottomsurface of base 250. First guide 256 is positioned on a first side ofbase 250 and extends from a front end to a back end of base 250, andsecond guide 258 is positioned on a second side of base 250 and extendsfrom a front end to a back end of base 250. Shaft 254 includes thirdguide 260 and fourth guide 262. Third guide 260 extends from a front endto a back end of shaft 254 on a first side of shaft 254, and fourthguide 262 extends from a front end to a back end of shaft 254 on asecond side of shaft 254. First guide 256, second guide 258, third guide260, and fourth guide 262 are configured to reduce friction as slider204 slides through surgical instrument 200 (shown in FIGS. 10A-10B).

Shaft 254 also includes bolt aperture 264 that extends from a front endto a back end of slider 204. Bolt aperture 264 is configured to receivea portion of bolt 208 of surgical instrument 200 (shown in FIGS.10A-10B). Shaft 254 further includes blade slot 266 that extends from afront end to a back end of slider 204. Blade slot 266 is configured toreceive a portion of blade 206 of surgical instrument 200 (shown inFIGS. 10A-10B). Shaft 254 also includes first shoulder 268 and secondshoulder 270. First shoulder 268 is a ridge on a first side of slider204, and second shoulder 270 is a ridge on a second side of slider 204.First shoulder 268 and second shoulder 270 are configured to slide alonglower arm 226 of body 202. Shaft 254 additionally includes device notch272. Device notch 272 is a groove on a front end of shaft 254. Devicenotch 272 is configured to receive a portion of subcutaneous device 100(shown in FIGS. 1-9).

FIG. 13A is a perspective view of blade 206 of surgical instrument 200.FIG. 13B is a side view of blade 206 of surgical instrument 200. Blade206 includes base 280, shaft 282, tip 284, and opening 286.

Blade 206 includes base 280, shaft 282, and tip 284. Base 280 forms aback end of blade 206. A back end of shaft 282 is connected to base 280.Tip 284 is connected to a front end of shaft 282. Tip 284 is a bladetip. Blade 206 also includes opening 286 that extends through base 280of blade 206. Opening 286 is configured to receive screw 210 of surgicalinstrument 200 (shown in FIGS. 10A-10B) to mount blade 206 in surgicalinstrument 200.

FIG. 14A is a perspective view of surgical instrument 200. FIG. 14B is across-sectional view of surgical instrument 200. Surgical instrument 200includes body 202, slider 204, blade 206, bolt 208, and screw 210. Body202 includes base 220, handle 222, upper arm 224, lower arm 226, sliderslot 228, bolt aperture 230, bolt aperture 232, blade slot 234, screwaperture 236, guide track 238, guide track 240, and prong track 242.Slider 204 includes base 250, knob 252, shaft 254, first guide 256,second guide 258, third guide 260, fourth guide 262, bolt aperture 264,blade slot 266, first shoulder 268, second shoulder 270, and devicenotch 272. Blade 206 includes base 280, shaft 282, tip 284, and opening286.

Surgical instrument 200 includes body 202, slider 204, blade 206, bolt208, and screw 210. Body 202 is described in reference to FIGS. 11A-11Dabove. Slider 204 is described in reference to FIGS. 12A-12D above.Blade 206 is described in reference to FIGS. 13A-13B above.

Slider 204 is positioned in and is capable of sliding in slider slot 228of body 202 of surgical instrument 200. Base 250 of slider 204 slidesalong on upper arm 224 of body 202 as slider 204 slides through sliderslot 228 of body 202. Bolt 208 extends through bolt aperture 230 in body202, bolt aperture 264 in slider 204, and into bolt aperture 232 in body202. Slider 204 can slide along bolt 208 as it slides through sliderslot 228 of body 202. In an alternate embodiment, bolt 208 can be ashaft or any other suitable mechanism upon which slider 204 can slide.Further, blade 206 extends through blade slot 266 of slider 204. Slider204 can slide along blade 206 as it slides through slider slot 228 ofbody 202. Slider 204 also includes first shoulder 268 and secondshoulder 270 that abut and slide along upper sides of lower arm 226 asslider 204 slides through slider slot 228 of body 202.

Slider 204 is a mechanism that can be manually pushed by a surgeon todeploy a device pre-loaded in surgical instrument 200 out of surgicalinstrument 200. In an alternate embodiment, slider 204 can be automaticand the device pre-loaded in surgical instrument 200 can beautomatically deployed out of surgical instrument 200.

Blade 206 is positioned in and mounted to body 202 of surgicalinstrument 200. Base 150 of blade 206 is positioned in blade slot 234 ofbody 202 so that opening 286 in base 150 of blade 206 is aligned withscrew aperture 236 in body 202. Screw 210 can be inserted throughopening 286 in base 280 of blade 206 and then screwed into screwaperture 236 of body 202 to mount blade 206 to body 202 of surgicalinstrument 200. When blade 206 is mounted in surgical instrument 202,tip 284 of blade 206 will extend past a front end of surgical instrument200 so that a surgeon can use tip 284 of blade 206 to cut through tissuein a patient. In an alternate embodiment, blade 206 can include a bluntedge that a surgeon can use to ensure that a pocket that is created forsubcutaneous device 100 is a correct width and depth.

Surgical instrument 200 can be used to implant subcutaneous device 100in a patient. Slider 204 of surgical instrument 200 acts as an injectionmechanism to inject subcutaneous device 100 onto a bone, a muscle, or atissue of a patient. When surgical instrument 200 is positioned adjacentto the bone, the muscle, or the tissue, a surgeon pushes slider 204 ofsurgical instrument 200 forward to inject subcutaneous device 100 ontothe bone, the muscle, or the tissue. A method for injecting thesubcutaneous device 100 onto the bone, the muscle, or the tissue isdescribed in greater detail below with reference to FIGS. 15-19.

Method 300

FIG. 15 is a flow chart showing method 300 for implanting subcutaneousdevice 100 using surgical instrument 200. FIGS. 16A-19 show subcutaneousdevice 100 at different positions in surgical instrument 200 assubcutaneous device 100 is being implanted with surgical instrument 200.FIG. 16A is a perspective view of subcutaneous device 100 in a firstposition in surgical instrument 200. FIG. 16B is a cross-sectional viewof subcutaneous device 100 in the first position in surgical instrument200. FIG. 17A is a perspective view of subcutaneous device 100 in asecond position in surgical instrument 200 as the subcutaneous device isbeing implanted. FIG. 17B is a cross-sectional view of subcutaneousdevice 100 in the second position in surgical instrument 200 assubcutaneous device 100 is being implanted. FIG. 17C is across-sectional view of subcutaneous device 100 in the second positionin surgical instrument 200 as subcutaneous device 100 is beingimplanted. FIG. 18A is a perspective view of subcutaneous device 100 ina third position in surgical instrument 200 as subcutaneous device 100is being implanted. FIG. 18B is a cross-sectional view of subcutaneousdevice 100 in the third position in surgical instrument 200 assubcutaneous device 100 is being implanted. FIG. 19 is a perspectiveview of subcutaneous device 100 after it has been deployed from surgicalinstrument 200. Subcutaneous device 100 includes housing 102, clip 104,and prong 106. Clip 104 includes top portion 140, bottom portion 142,spring portion 144, and slot 150. Prong 106 includes spring portion 144.Surgical instrument 200 includes body 202, slider 204, blade 206, bolt208, and screw 210. Body 202 includes base 220, handle 222, and sliderslot 228. Slider 204 includes shaft 254 and knob 252. Blade 206 includestip 284. Method 300 includes steps 302-314.

Method 300 is described here in relation to implanting subcutaneousdevice 100 (shown in FIGS. 1-9) on a xiphoid process and a sternum of apatient. However, method 300 can be used to implant any suitable medicaldevice (including any of subcutaneous devices 400, 500, 600, 700, 800,900, 1000, 1100, 1200, 1300, 1400, and 1500 shown in FIGS. 20-37) on anybone, muscle, or tissue in a patient. Further, method 300 is describedhere in relation to using surgical instrument 200 (shown in FIGS.10A-14B) to implant subcutaneous device 100. However, any suitablesurgical instrument 200 can be used to implant subcutaneous device 100.

Step 302 includes making a small incision in a patient below a xiphoidprocess. The patient may be under local or general anesthesia. A surgeoncan make a small incision through the skin right below the xiphoidprocess using a scalpel.

Step 304 includes inserting surgical instrument 200 through the smallincision. Surgical instrument 200 will be pre-loaded with subcutaneousdevice 100 when it is inserted through the small incision, as shown inFIGS. 16A-16B. When surgical instrument 200 is pre-loaded withsubcutaneous device 100, surgical instrument 200 will be in a firstposition. In the first position, shaft 254 of slider 204 of surgicalinstrument 200 will abut base 220 of body 202 of surgical instrument200. Subcutaneous device 100 is loaded into surgical instrument 200 sothat a front end of subcutaneous device 100 is aligned with a front endof surgical instrument 200. A back end of subcutaneous device 100 willabut slider 204 of surgical instrument 200. Spring portion 144 of clip104 of subcutaneous device 100 will be positioned in device notch 272 ofslider 204 of surgical instrument 200. First guide 130 and second guide132 of housing 102 of subcutaneous device 100 sit in guide track 238 andguide track 240 of body 202 of surgical instrument 200, respectively.Blade 206 of surgical instrument 200 will extend through slot 150 ofclip 104 of subcutaneous device 100. Tip 284 of blade 206 will extendpast a front end of subcutaneous device 100, allowing tip 284 of blade206 to be used to cut tissue in the patient.

Step 306 includes advancing surgical instrument 200 to the xiphoidprocess and a distal end of the sternum. A surgeon who is holding handle222 of body 202 of surgical instrument 200 can move surgical instrument200 into and through the patient. The surgeon can manipulate surgicalinstrument 200 to use tip 284 of blade 206 of surgical instrument 200 tocut tissue in the patient to provide a pathway to the xiphoid processand the distal end of the sternum.

Step 308 includes removing tissue from the xiphoid process and a distalend of the sternum using blade 206 of surgical instrument 200. A surgeoncan manipulate surgical instrument 200 to use tip 284 of blade 206 ofsurgical instrument 200 to scrape tissue on the xiphoid process and thedistal end of the sternum off to expose the xiphoid process and thedistal end of the sternum. In an alternate embodiment, a surgeon can usea scalpel or other surgical instrument to scrape tissue off of thexiphoid process and the distal end of the sternum.

Step 310 includes positioning surgical instrument 200 to deploysubcutaneous device 100 onto the xiphoid process and the distal end ofthe sternum. After the xiphoid process and the distal end of the sternumhave been exposed, the surgeon can position surgical instrument 200 inthe patient so that blade 206 of surgical instrument 200 is positionedto abut the top side of the xiphoid process and the distal end of thesternum. In this position, prong 206 of subcutaneous device 100 will bepositioned beneath the xiphoid process and the distal end of thesternum. Further, the surgeon can adjust the position of subcutaneousdevice 100 with surgical instrument 200 to ensure that prong 106 hasgood contact with the pericardium, fat, muscle, or tissue.

Step 312 includes pushing subcutaneous device 100 onto the xiphoidprocess and the distal end of the sternum using surgical instrument 200.Subcutaneous device 100 is pushed out of surgical instrument 200 andonto the xiphoid process and the distal end of the sternum by pushingslider 204 of surgical instrument 200. FIGS. 17A-17C show surgicalinstrument 200 in a second position. In the second position, slider 204of surgical instrument 200 has been pushed halfway through slider slot228 of body 202 of surgical instrument 200. Further, in the secondposition, subcutaneous device 100 is pushed partially out of surgicalinstrument 200. FIGS. 18A-18B show surgical instrument 200 in a thirdposition. In the third position, slider 204 of surgical instrument 200has been pushed to the front end slider slot 228 of body 202 of surgicalinstrument 200. Further, in the third position, subcutaneous device 100is pushed almost fully out of surgical instrument 100.

The surgeon will push knob 252 of slider 204 of surgical instrument 200along slider slot 228 of body 202 of surgical instrument 200. As slider204 is pushed through surgical instrument 200, subcutaneous device 100is pushed out of surgical instrument 200. As subcutaneous device 100 ispushed out of surgical instrument 200, first guide 130 and second guide132 of housing 102 of subcutaneous device 100 slide along guide track238 and guide track 240 of body 202 of surgical instrument 200,respectively, as shown in FIG. 17C. As subcutaneous device 100 is pushedout of surgical instrument 200, subcutaneous device 100 will be pushedon the xiphoid process and the distal end of the sternum of the patient.In an alternate embodiment, surgical instrument 200 can be configured toautomatically advance subcutaneous device 100 out of surgical instrument200 and onto the xiphoid process and the distal end of the sternum.

Step 314 includes anchoring subcutaneous device 100 onto the xiphoidprocess and the distal end of the sternum. As subcutaneous device 100 ispushed out of surgical instrument 200, top portion 140 of clip 104 ofsubcutaneous device 100 will be pushed on top of the xiphoid process andthe distal end of the sternum, and bottom portion 142 of clip 104,housing 102, and prong 106 of subcutaneous device 100 will be pushedunderneath the xiphoid process and the distal end of the sternum.Subcutaneous device 100 will be pushed onto the xiphoid process and thedistal end of the sternum until spring portion 144 of clip 104 ofsubcutaneous device 100 abuts the xiphoid process. The tension in springportion 144 of clip 104 of subcutaneous device 100 will force topportion 140 of clip 104 of subcutaneous device 100 down onto the xiphoidprocess and the distal end of the sternum. This tension will anchorsubcutaneous device 100 onto the xiphoid process and the distal end ofthe sternum.

When subcutaneous device 100 is stowed in surgical instrument 200, prong106 of subcutaneous device 100 is positioned in channel 128 of housing102 of subcutaneous device 100. When subcutaneous device 100 is deployedand anchored to the xiphoid process and the distal end of the sternum,spring portion 166 of prong 106 will push arm portion 168 and contactportion 170 downwards and away from housing 102. As subcutaneous device100 is implanted onto the xiphoid process and the distal end of thesternum, prong 106 will push through tissue in the anterior mediastinum.When subcutaneous device 100 is implanted on the xiphoid process and thedistal end of the sternum, contact portion 170 of prong 106 should bepositioned on the right ventricle of the heart. A surgeon can check andadjust the placement of prong 106 as needed during implantation ofsubcutaneous device 100.

Step 316 includes removing surgical instrument 200 from the smallincision in the patient. After subcutaneous device 100 has been anchoredonto the xiphoid process and the distal end of the sternum, surgicalinstrument 200 can be removed from the small incision in the patient, asshown in FIG. 19. When surgical instrument 200 is removed, subcutaneousdevice 100 will remain anchored to the xiphoid process and the distalend of the sternum.

Subcutaneous device 100 remains anchored to the xiphoid process and thedistal end of the sternum due to the tension being put on top portion140 of clip 104 from spring portion 144 of clip 104. The tension of clip104 will hold subcutaneous device 100 in position on the xiphoid processand the distal end of the sternum, with little risk that subcutaneousdevice 100 will move. Two to four weeks post-surgery, fibrosis willbegin to develop around subcutaneous device 100. The fibrosis thatdevelops around subcutaneous device 100 will further hold subcutaneousdevice 100 in position in the patient.

If subcutaneous device 100 needs to be removed from the patient withintwo to four weeks post-surgery and before fibrosis has formed aroundsubcutaneous device 100, a surgeon can make a small incision below thexiphoid process and insert an instrument through the small incision topull subcutaneous device 100 out of the patient. The instrument willlift top portion 140 of clip 104 of subcutaneous device 100 and pullclip 104 of subcutaneous device 100 off of the xiphoid process and thedistal end of the sternum, thus removing subcutaneous device 100 fromthe patient. The instrument that is used to remove subcutaneous device100 can be the same instrument used to insert subcutaneous device 100 ora separate instrument.

If subcutaneous device 100 needs to be removed from the patient afterfibrosis has formed around subcutaneous device 100, a surgeon can use ascalpel and other surgical instruments to cut through the skin, tissue,and fibrosis to access subcutaneous device 100. The surgeon can then useany suitable instrument to remove subcutaneous device 100 from thepatient.

Method 300 is a non-invasive surgery. Leads are not implanted in thevasculature of the patient using invasive techniques. Rather,subcutaneous device 100 is anchored to the xiphoid process and thedistal end of the sternum using surgical instrument 200 and prong 106extends through the anterior mediastinum and comes into contact with theheart. This lowers the risk of infection, complications during surgery,and potential failure of the device. Method 300 can be used to implantsubcutaneous device 300 on any bone, muscle, or tissue in the body of apatient. In an alternate embodiment, any suitable method, includingtraditional surgical methods, and any suitable instrument can be used toimplant subcutaneous device 100.

FIGS. 20-37 below show different embodiments of subcutaneous device 100.These embodiments are intended to be exemplary. Subcutaneous device 100can have any suitable design and function. Each of the embodiments shownin FIGS. 20-37 below can be implanted into the patient using surgicalinstrument 200 shown in FIGS. 10A-14B and/or using method 300 shown inFIGS. 15-19. As shown in the different embodiments of subcutaneousdevice 100 shown in FIGS. 20-37 below, subcutaneous device 100 caninclude any suitable number of prongs 106. Prongs 106 can have anysuitable length and shape to be positioned and/or come into contact withvarious organs, nerves, and tissues in the patient's body. Further,subcutaneous device 100 can function as a monitoring device, adiagnostic device, a pacemaker device, a defibrillator device, or anycombinations thereof.

Subcutaneous Device 400

FIG. 20 is a perspective view of subcutaneous device 400. Subcutaneousdevice 400 includes housing 402, clip 404, and prong 406. Housing 402includes first side 410, second side 412, top side 414, bottom side 416,front end 418, back end 420, curved surface 422, recess 424, port 426,channel 428, first guide 430 (not shown in FIG. 20), second guide 432,electrode 434, and electrode 436. Clip 404 includes top portion 440,bottom portion 442, spring portion 444, tip 446, openings 448, slot 450,and electrode 452. Prong 406 includes proximal end 460 (not shown inFIG. 20), distal end 462, base portion 464, spring portion 466, armportion 468, contact portion 470, and electrode 472.

Subcutaneous device 400 includes housing 402, clip 404, and prong 406.Housing 402 has the same general structure and design as housing 102 ofsubcutaneous device 100 shown in FIGS. 1-9C. Clip 404 has the samegeneral structure and design as clip 104 of subcutaneous device 100shown in FIGS. 1-9C. The reference numerals that refer to the parts ofhousing 402 and clip 404 are incremented by three-hundred compared tothe reference numerals that refer to the parts of housing 102 and clip104 of subcutaneous device 100 shown in FIGS. 1-9C.

Prong 406 includes the same parts as prong 106 of subcutaneous device100 as shown in FIGS. 1-9C, and the reference numerals that refer to theparts of prong 406 are incremented by three-hundred compared to thereference numerals that refer to the parts of prong 106 of subcutaneousdevice 100 shown in FIGS. 1-9C. However, prong 406 has a differentshape. Spring portion 466 and arm portion 468 extend away from firstside 410 of housing 402. Contact portion 470 is a portion of prong 406adjacent to distal end 462 of prong 406 that is configured to come intocontact with a left ventricle of a patient's heart. Electrode 472positioned on contact portion 470 will also come into contact with aleft ventricle of a patient's heart.

In one example, subcutaneous device 400 can be anchored to a xiphoidprocess and a sternum of a patient. Clip 404 is configured to anchorsubcutaneous device 400 to the xiphoid process and the sternum. Clip 404will expand as it is slid around the xiphoid process and the sternum.Spring portion 444 acts as a spring for clip 404 and is under tension.Top portion 440 acts as a tension arm and the forces from spring portion444 translate to and push down on top portion 440. When clip 404 ispositioned on the xiphoid process and the sternum, the tension in springportion 444 will force top portion 440 down onto the xiphoid process andthe sternum to anchor clip 404 to the xiphoid process and the sternum.Further, sutures, tines, pins, or screws can be inserted throughopenings 448 on top portion 440 of clip 404 to further anchorsubcutaneous device 400 to the xiphoid process and the sternum.

Subcutaneous device 400 can include a power source, a controller, amemory, a transceiver, sensors, sensing circuitry, therapeuticcircuitry, electrodes, and/or any other component of a medical device.In the embodiment shown in FIG. 20, subcutaneous device 400 isconfigured to be a single chamber pacemaker. Any one or combination ofelectrode 434, electrode 436, electrode 452, and electrode 472 can sensethe electrical activity of a heart. The sensed electrical activity canbe transmitted to the sensing circuitry and the controller in housing402 of subcutaneous device 400. The controller can determine the heartrate of the patient and can detect whether an arrhythmia is present. Ifan arrhythmia is detected, the controller can send instructions totherapeutic circuitry to provide a therapeutic electrical stimulation tothe heart. Specifically, a therapeutic electrical stimulation can beprovided to the left ventricle. In this manner, subcutaneous device 400functions as a monitoring device, a diagnostic device, and a therapeuticdevice. In alternate embodiments, subcutaneous device 400 can functiononly as a monitoring device, a diagnostic device, a therapeutic device,or any combinations thereof.

Subcutaneous Device 500

FIG. 21A is a perspective view of subcutaneous device 500. FIG. 21B is aside view of subcutaneous device 500. Subcutaneous device 500 includeshousing 502, clip 504, and prong 506. Housing 502 includes first side510, second side 512, top side 514, bottom side 516, front end 518, backend 520, curved surface 522, recess 524, port 526, channel 528, firstguide 530, second guide 532, electrode 534, and electrode 536. Clip 504includes top portion 540, bottom portion 542, spring portion 544, tip546, openings 548, slot 550, and electrode 552. Prong 506 includesproximal end 560 (not shown in FIGS. 21A-21B), distal end 562, baseportion 564, spring portion 566, arm portion 568, contact portion 570,and defibrillator coil 574.

Subcutaneous device 500 includes housing 502, clip 504, and prong 506.Housing 502 has the same general structure and design as housing 102 ofsubcutaneous device 100 shown in FIGS. 1-9C. Clip 504 has the samegeneral structure and design as clip 104 of subcutaneous device 100shown in FIGS. 1-9C. The reference numerals that refer to the parts ofhousing 502 and clip 504 are incremented by four-hundred compared to thereference numerals that refer to the parts of housing 102 and clip 104of subcutaneous device 100 shown in FIGS. 1-9C.

Prong 506 generally includes the same parts as prong 106 of subcutaneousdevice 100 as shown in FIGS. 1-9C, and the reference numerals that referto the parts of prong 506 are incremented by four-hundred compared tothe reference numerals that refer to the parts of prong 106 ofsubcutaneous device 100 shown in FIGS. 1-9C. However, prong 406 has adifferent shape and includes defibrillator coil 574 instead of anelectrode at distal end 562. Spring portion 566 and arm portion 568extend away from bottom side 520 of housing 502. Contact portion 570 isa portion of prong 506 adjacent to distal end 562 of prong 506 that isconfigured to come into contact with tissue inferior to a patient'sheart. Defibrillator coil 574 is positioned on contact portion 570adjacent to distal end 562 of prong 506. When an electrical signal isdelivered to defibrillator coil 574, defibrillator coil 574 will createa vector with electrode 534 on front end 518 of housing 502. In theembodiment shown, defibrillator coil 574 serves as the negativeelectrode and electrode 534 serves as the positive electrode. However,in alternate embodiments this can be reversed. Prong 506 is positionedso that distal end 562, and thus contact portion 570 and defibrillatorcoil 574, are positioned inferior to the heart. Thus, the vector createdbetween defibrillator coil 574 and electrode 534 will pass through apatient's heart to provide a high voltage electrical shock to thepatient's heart.

In one example, subcutaneous device 500 can be anchored to a xiphoidprocess and a sternum of a patient. Clip 504 is configured to anchorsubcutaneous device 500 to the xiphoid process and the sternum. Clip 504will expand as it is slid around the xiphoid process and the sternum.Spring portion 544 acts as a spring for clip 504 and is under tension.Top portion 540 acts as a tension arm and the forces from spring portion544 translate to and push down on top portion 540. When clip 504 ispositioned on the xiphoid process and the sternum, the tension in springportion 544 will force top portion 540 down onto the xiphoid process andthe sternum to anchor clip 504 to the xiphoid process and the sternum.Further, sutures, tines, pins, or screws can be inserted throughopenings 548 on top portion 540 of clip 504 to further anchorsubcutaneous device 500 to the xiphoid process and the sternum.

Subcutaneous device 500 can include a power source, a controller, amemory, a transceiver, sensors, sensing circuitry, therapeuticcircuitry, electrodes, and/or any other component of a medical device.In the embodiment shown in FIGS. 21A-21B, subcutaneous device 500 isconfigured to be a defibrillator. Any one or combination of electrode534, electrode 536, and electrode 552 can sense the electrical activityof a heart. Further, defibrillator coil 574 can act as an electrode thatsenses the electrical activity of the heart. The sensed electricalactivity can be transmitted to the sensing circuitry and the controllerin housing 502 of subcutaneous device 500. The controller can determinethe heart rate of the patient and can detect whether an abnormality ispresent. If an abnormality is detected, the controller can sendinstructions to therapeutic circuitry to provide a high voltageelectrical shock to the heart using defibrillator coil 574. In thismanner, subcutaneous device 500 functions as a monitoring device, adiagnostic device, and a therapeutic device. In alternate embodiments,subcutaneous device 500 can function only as a monitoring device, adiagnostic device, or a therapeutic device, or any combinations thereof.

Subcutaneous Device 600

FIG. 22A is a perspective view of subcutaneous device 600. FIG. 22B is atop view of subcutaneous device 600. FIG. 22C is a bottom view ofsubcutaneous device 600. FIG. 22D is a side view of subcutaneous device600. FIG. 22E is a back view of subcutaneous device 600. FIG. 23A is aperspective view of subcutaneous device 600 positioned on xiphoidprocess X and sternum S and showing a positioning of prongs 606A and606B on left lung LL and right lung RL. FIG. 23B is a front view ofsubcutaneous device 600 positioned on xiphoid process X and sternum Sand showing a positioning of prongs 606A and 606B on left lung LL andright lung RL. FIG. 23C is a side view of subcutaneous device 600positioned on xiphoid process X and sternum S and showing a positioningof prongs 606A and 606B on left lung LL and right lung RL. Subcutaneousdevice 600 includes housing 602, clip 604, prong 606A, and prong 606B.Housing 602 includes first side 610, second side 612, top side 614,bottom side 616, front end 618, back end 620, curved surface 622, recess624, port 626A, port 626B, channel 628A, channel 628B, first guide 630,second guide 632, electrode 634, and electrode 636. Clip 604 includestop portion 640, bottom portion 642, spring portion 644, tip 646,openings 648, slot 650, and electrode 652. Prong 606A includes proximalend 660A (not shown in FIGS. 22A-22B), distal end 662A, base portion664A, spring portion 666A, arm portion 668A, contact portion 670A, andelectrode 672A. Prong 606B includes proximal end 660B (not shown inFIGS. 22A-22B), distal end 662B, base portion 664B, spring portion 666B,arm portion 668B, contact portion 670B, and electrode 672B. FIGS.23A-23C show xiphoid process X, sternum S, left lung LL, and right lungRL. FIG. 23B also shows ribs R.

Subcutaneous device 600 includes housing 602, clip 604, prong 606A, andprong 606B. Housing 602 has the same general structure and design ashousing 102 of subcutaneous device 100 shown in FIGS. 1-9C. However,housing 602 includes two ports, including port 626A and port 626B, andtwo channels, including channel 628A and channel 628B. The referencenumerals that refer to the parts of housing 602 are incremented byfive-hundred compared to the reference numerals that refer to the partsof housing 102 of subcutaneous device 100 shown in FIGS. 1-9C. Port 626Aand port 626B are positioned next to one another on housing 602, andchannel 628A and channel 628B are positioned next to one another onhousing 602. Prong 606A is configured to be connected to port 626A andcan be positioned in channel 628A when subcutaneous device 600 is in astowed position. Prong 606B is configured to be connected to port 626Band can be positioned in channel 628B when subcutaneous device 600 is ina stowed position.

Clip 604 has the same general structure and design as clip 104 ofsubcutaneous device 100 shown in FIGS. 1-9C. The reference numerals thatrefer to the parts of clip 604 are incremented by five-hundred comparedto the reference numerals that refer to the parts of clip 104 ofsubcutaneous device 100 shown in FIGS. 1-9C.

Prong 606A and prong 606B each include the same parts as prong 106 ofsubcutaneous device 100 as shown in FIGS. 1-9C, and the referencenumerals that refer to the parts of prong 606A and prong 606B areincremented by five-hundred compared to the reference numerals thatrefer to the parts of prong 106 of subcutaneous device 100 shown inFIGS. 1-9C. However, prong 606A and 606B have different shapes thanprong 106 shown in FIGS. 1-9C. Spring portion 666A and arm portion 668Aof prong 606A extend away from first side 610 of housing 602. Contactportion 670A is a portion of prong 606A adjacent to distal end 662A ofprong 606A that is configured to come into contact with left lung LL ofa patient. Electrode 672A positioned on contact portion 670A will alsocome into contact with left lung LL. Spring portion 666B and arm portion668B of prong 606B extend away from second side 612 of housing 602.Contact portion 670B is a portion of prong 606B adjacent to distal end662B of prong 606B that is configured to come into contact with rightlung RL of a patient. Electrode 672B positioned on contact portion 670Bwill also come into contact with right lung RL.

In one example, subcutaneous device 600 can be anchored to xiphoidprocess X and sternum S of a patient. Clip 604 is configured to anchorsubcutaneous device 600 to xiphoid process X and sternum S. Clip 604will expand as it is slid around xiphoid process X and sternum S. Springportion 644 acts as a spring for clip 604 and is under tension. Topportion 640 acts as a tension arm and the forces from spring portion 644translate to and push down on top portion 640. When clip 604 ispositioned on xiphoid process X and sternum S, the tension in springportion 644 will force top portion 640 down onto xiphoid process X andsternum S to anchor clip 604 to xiphoid process X and sternum S.Further, sutures, tines, pins, or screws can be inserted throughopenings 648 on top portion 640 of clip 604 to further anchorsubcutaneous device 600 to xiphoid process X and sternum S.

Subcutaneous device 600 can include a power source, a controller, amemory, a transceiver, sensors, sensing circuitry, electrodes, and/orany other component of a medical device. In the embodiment shown inFIGS. 22A-23C, subcutaneous device 600 is configured to be a pulmonarymonitoring and diagnostic device. Any one or combination of electrode634, electrode 636, electrode 652, electrode 672A, and electrode 672Bcan sense the electrical activity of left lung LL, right lung RL, andtissue surrounding left lung LL and right lung RL. The sensed electricalactivity can be transmitted to the sensing circuitry and the controllerin housing 602 of subcutaneous device 600. The controller can determinephysiological parameters of the patient for monitoring and diagnosticpurposes. In this manner, subcutaneous device 600 functions as amonitoring device and a diagnostic device. In alternate embodiments,subcutaneous device 600 can function only as a monitoring device or adiagnostic device.

Subcutaneous Device 700

FIG. 24A is a top view of subcutaneous device 700. FIG. 24B is a bottomview of subcutaneous device 700. FIG. 24C is a side view of subcutaneousdevice 700. FIG. 24D is a front view of subcutaneous device 700. FIG.25A is a front view of subcutaneous device 700 positioned on xiphoidprocess X and sternum S and showing a positioning of prongs 706A and706B around heart H. FIG. 25B is a perspective view of subcutaneousdevice 700 positioned on xiphoid process X and sternum S and showing apositioning of prongs 706A and 706B around heart H. Subcutaneous device700 includes housing 702, clip 704, prong 706A, and prong 706B. Housing702 includes first side 710, second side 712, top side 714, bottom side716, front end 718, back end 720, curved surface 722, recess 724, port726A, port 726B, channel 728A, channel 728B, first guide 730, secondguide 732, electrode 734, and electrode 736. Clip 704 includes topportion 740, bottom portion 742, spring portion 744, tip 746, openings748, slot 750, and electrode 752. Prong 706A includes proximal end 760A(not shown in FIGS. 24A-25B), distal end 762A, base portion 764A, springportion 766A, arm portion 768A, contact portion 770A, and electrode772A. Prong 706B includes proximal end 760B (not shown in FIGS.24A-25B), distal end 762B, base portion 764B, spring portion 766B, armportion 768B, contact portion 770B, and electrode 772B. FIGS. 25A-25Bshow xiphoid process X, sternum S, and heart H.

Subcutaneous device 700 includes housing 702, clip 704, prong 706A, andprong 706B. Housing 702 has the same general structure and design ashousing 102 of subcutaneous device 100 shown in FIGS. 1-9C. However,housing 702 includes two ports, including port 726A and port 726B, andtwo channels, including channel 728A and channel 728B. The referencenumerals that refer to the parts of housing 702 are incremented bysix-hundred compared to the reference numerals that refer to the partsof housing 102 of subcutaneous device 100 shown in FIGS. 1-9C. Port 726Aand port 726B are positioned next to one another on housing 702, andchannel 728A and channel 728B are positioned next to one another onhousing 702. Prong 706A is configured to be connected to port 726A andcan be positioned in channel 728A when subcutaneous device 700 is in astowed position. Prong 706B is configured to be connected to port 726Band can be positioned in channel 728B when subcutaneous device 700 is ina stowed position.

Clip 704 has the same general structure and design as clip 104 ofsubcutaneous device 100 shown in FIGS. 1-9C. The reference numerals thatrefer to the parts of clip 704 are incremented by six-hundred comparedto the reference numerals that refer to the parts of clip 104 ofsubcutaneous device 100 shown in FIGS. 1-9C.

Prong 706A and prong 706B each include the same parts as prong 106 ofsubcutaneous device 100 as shown in FIGS. 1-9C, and the referencenumerals that refer to the parts of prong 706A and prong 706B areincremented by six-hundred compared to the reference numerals that referto the parts of prong 106 of subcutaneous device 100 shown in FIGS.1-9C. However, prong 706A and 706B have a different shape than prong 106shown in FIGS. 1-9C. Spring portion 766A and arm portion 768A of prong706A extend away from first side 710 of housing 702. Contact portion770A is a portion of prong 706A adjacent to distal end 762A of prong706A that is configured to come into contact with tissue surroundingheart H of a patient. Electrode 772A positioned on contact portion 770Awill also come into contact with tissue surrounding heart H of apatient. Spring portion 766B and arm portion 768B of prong 706B extendaway from second side 712 of housing 702. Contact portion 770B is aportion of prong 706B adjacent to distal end 762B of prong 706B that isconfigured to come into contact with tissue surrounding heart H of apatient. Electrode 772B positioned on contact portion 770B will alsocome into contact with tissue surrounding heart H of a patient.

In one example, subcutaneous device 700 can be anchored to xiphoidprocess X and sternum S of a patient. Clip 704 is configured to anchorsubcutaneous device 700 to xiphoid process X and sternum S. Clip 704will expand as it is slid around xiphoid process X and sternum S. Springportion 744 acts as a spring for clip 704 and is under tension. Topportion 740 acts as a tension arm and the forces from spring portion 744translate to and push down on top portion 740. When clip 704 ispositioned on xiphoid process X and sternum S, the tension in springportion 744 will force top portion 740 down onto xiphoid process X andsternum S to anchor clip 704 to xiphoid process X and sternum S.Further, sutures, tines, pins, or screws can be inserted throughopenings 748 on top portion 740 of clip 704 to further anchorsubcutaneous device 700 to xiphoid process X and sternum S.

Subcutaneous device 700 can include a power source, a controller, amemory, a transceiver, sensors, sensing circuitry, electrodes, and/orany other component of a medical device. In the embodiment shown inFIGS. 24A-25B, subcutaneous device 700 is configured to be a cardiacmonitoring and diagnostic device. Any one or combination of electrode734, electrode 736, electrode 752, electrode 772A, and electrode 772Bcan sense the electrical activity of tissue surrounding heart H. Thesensed electrical activity can be transmitted to the sensing circuitryand the controller in housing 702 of subcutaneous device 700. Thecontroller can determine physiological parameters of the patient formonitoring and diagnostic purposes. In this manner, subcutaneous device700 functions as a monitoring device and a diagnostic device. Inalternate embodiments, subcutaneous device 700 can function only as amonitoring device or a diagnostic device.

Specifically, in the embodiment shown in FIGS. 24A-25B, a surface ECG ofheart H can be determined using electrode 734, electrode 736, electrode772A, and electrode 772B. A first lead can be determined betweenelectrode 734 and electrode 736 on housing 702 of subcutaneous device700. A second lead can be determined between electrode 772A on firstprong 706A and electrode 772B on second prong 706B. The informationgathered from these two leads can then be extrapolated to give thesurface ECG across six leads. Anchoring subcutaneous device 700 toxiphoid process X and sternum S allows for consistency and accuracy inthe surface ECG readings, as subcutaneous device 700 is not movingwithin the body and causing the ECG morphology to change.

Subcutaneous Device 800

FIG. 26 is a perspective view of subcutaneous device 800. Subcutaneousdevice 800 includes housing 802, clip 804, prong 806A, and prong 806B.Housing 802 includes first side 810, second side 812, top side 814,bottom side 816, front end 818, back end 820, curved surface 822, recess824, port 826A, port 826B, channel 828A, channel 828B, first guide 830(now shown in FIG. 26) second guide 832, electrode 834, and electrode836. Clip 804 includes top portion 840, bottom portion 842, springportion 844, tip 846, openings 848, slot 850, and electrode 852. Prong806A includes proximal end 860A (not shown in FIG. 26), distal end 862A,base portion 864A, spring portion 866A, arm portion 868A, contactportion 870A, and electrode 872A. Prong 806B includes proximal end 860B(not shown in FIG. 26), distal end 862B, base portion 864B, springportion 866B, arm portion 868B, contact portion 870B, and electrode872B.

Subcutaneous device 800 includes housing 802, clip 804, prong 806A, andprong 806B. Housing 802 has the same general structure and design ashousing 102 of subcutaneous device 100 shown in FIGS. 1-9C. However,housing 802 includes two ports, including port 826A and port 826B, andtwo channels, including channel 828A and channel 828B. The referencenumerals that refer to the parts of housing 802 are incremented byseven-hundred compared to the reference numerals that refer to the partsof housing 102 of subcutaneous device 100 shown in FIGS. 1-9C. Port 826Aand port 826B are positioned next to one another on housing 802, andchannel 828A and channel 828B are positioned next to one another onhousing 802. Prong 806A is configured to be connected to port 826A andcan be positioned in channel 828A when subcutaneous device 800 is in astowed position. Prong 806B is configured to be connected to port 826Band can be positioned in channel 828B when subcutaneous device 800 is ina stowed position.

Clip 804 has the same general structure and design as clip 104 ofsubcutaneous device 100 shown in FIGS. 1-9C. The reference numerals thatrefer to the parts of clip 804 are incremented by seven-hundred comparedto the reference numerals that refer to the parts of clip 104 ofsubcutaneous device 100 shown in FIGS. 1-9C.

Prong 806A and prong 806B each include the same parts as prong 106 ofsubcutaneous device 100 as shown in FIGS. 1-9C, and the referencenumerals that refer to the parts of prong 806A and prong 806B areincremented by seven-hundred compared to the reference numerals thatrefer to the parts of prong 106 of subcutaneous device 100 shown inFIGS. 1-9C. However, prong 806A has a different shape than prong 106shown in FIGS. 1-9C. Spring portion 866A and arm portion 868A of prong806A extend away from first side 810 of housing 802. Contact portion870A is a portion of prong 806A adjacent to distal end 862A of prong806A that is configured to come into contact with the left ventricle ofthe patient's heart. Electrode 872A positioned on contact portion 870Awill also come into contact with the left ventricle of the patient'sheart. Prong 806B has the same shape as prong 106 shown in FIGS. 1-9C.Spring portion 866B and arm portion 868B of prong 806B extend underneathbottom side 816 of housing 802. Contact portion 870B is a portion ofprong 806B adjacent to distal end 862B of prong 806B that is configuredto come into contact with the right ventricle of a patient's heart.Electrode 872B positioned on contact portion 870B will also come intocontact with the right ventricle of patient's heart.

In one example, subcutaneous device 800 can be anchored to a xiphoidprocess and a sternum of a patient. Clip 804 is configured to anchorsubcutaneous device 800 to the xiphoid process and the sternum. Clip 804will expand as it is slid around the xiphoid process and the sternum.Spring portion 844 acts as a spring for clip 804 and is under tension.Top portion 840 acts as a tension arm and the forces from spring portion844 translate to and push down on top portion 840. When clip 804 ispositioned on the xiphoid process and the sternum, the tension in springportion 844 will force top portion 840 down onto the xiphoid process andthe sternum to anchor clip 804 to the xiphoid process and the sternum.Further, sutures, tines, pins, or screws can be inserted throughopenings 848 on top portion 840 of clip 804 to further anchorsubcutaneous device 800 to the xiphoid process and the sternum.

Subcutaneous device 800 can include a power source, a controller, amemory, a transceiver, sensors, sensing circuitry, therapeuticcircuitry, electrodes, and/or any other component of a medical device.In the embodiment shown in FIG. 26, subcutaneous device 800 isconfigured to be a dual chamber pacemaker. Any one or combination ofelectrode 834, electrode 836, electrode 852, electrode 872A, andelectrode 872B can sense the electrical activity of a heart. The sensedelectrical activity can be transmitted to the sensing circuitry and thecontroller in housing 802 of subcutaneous device 800. The controller candetermine the heart rate of the patient and can detect whether anarrhythmia is present. If an arrhythmia is detected, the controller cansend instructions to therapeutic circuitry to provide a therapeuticelectrical stimulation to the heart. Specifically, a therapeuticelectrical stimulation can be provided to the right ventricle and theleft ventricle. In this manner, subcutaneous device 800 functions as amonitoring device, a diagnostic device, and a therapeutic device. Inalternate embodiments, subcutaneous device 800 can function only as amonitoring device, a diagnostic device, or a therapeutic device, or anycombinations thereof.

Subcutaneous Device 900

FIG. 27 is a perspective view of subcutaneous device 900. FIG. 28 is acut-away perspective view of subcutaneous device 900 positioned onxiphoid process X and sternum S and showing a positioning of prongs 906Aand 906B on heart H. Subcutaneous device 900 includes housing 902, clip904, prong 906A, and prong 906B. Housing 902 includes first side 910,second side 912, top side 914, bottom side 916, front end 918, back end920, curved surface 922, recess 924, port 926A, port 926B, channel 928A,channel 928B, first guide 930 (not shown in FIG. 27), second guide 932,electrode 934, and electrode 936. Clip 904 includes top portion 940,bottom portion 942, spring portion 944, tip 946, openings 948, slot 950,and electrode 952. Prong 906A includes proximal end 960A (not shown inFIGS. 27-28), distal end 962A, base portion 964A, spring portion 966A,arm portion 968A, contact portion 970A, and electrode 972A. Prong 906Bincludes proximal end 960B (not shown in FIGS. 27-28), distal end 962B,base portion 964B, spring portion 966B, arm portion 968B, contactportion 970B, and electrode 972B. FIG. 28 shows xiphoid process X,sternum S, heart H, right ventricle RV, and right atrium RA.

Subcutaneous device 900 includes housing 902, clip 904, prong 906A, andprong 906B. Housing 902 has the same general structure and design ashousing 102 of subcutaneous device 100 shown in FIGS. 1-9C. However,housing 902 includes two ports, including port 926A and port 926B, andtwo channels, including channel 928A and channel 928B. The referencenumerals that refer to the parts of housing 902 are incremented byeight-hundred compared to the reference numerals that refer to the partsof housing 102 of subcutaneous device 100 shown in FIGS. 1-9C. Port 926Aand port 926B are positioned next to one another, and channel 928A andchannel 928B are positioned next to one another. Prong 906A isconfigured to be connected to port 926A and can be positioned in channel928A when subcutaneous device 900 is in a stowed position. Prong 906B isconfigured to be connected to port 926B and can be positioned in channel928B when subcutaneous device 900 is in a stowed position.

Clip 904 has the same general structure and design as clip 104 ofsubcutaneous device 100 shown in FIGS. 1-9C. The reference numerals thatrefer to the parts of clip 904 are incremented by eight-hundred comparedto the reference numerals that refer to the parts of clip 104 ofsubcutaneous device 100 shown in FIGS. 1-9C.

Prong 906A and prong 906B each include the same parts as prong 106 ofsubcutaneous device 100 as shown in FIGS. 1-9C, and the referencenumerals that refer to the parts of prong 906A and prong 906B areincremented by eight-hundred compared to the reference numerals thatrefer to the parts of prong 106 of subcutaneous device 100 shown inFIGS. 1-9C. Prong 906A has the same shape as prong 106 shown in FIGS.1-9C. Spring portion 966A and arm portion 968A of prong 906A extendunderneath bottom side 916 of housing 902. Contact portion 970A is aportion of prong 906A adjacent to distal end 962A of prong 906A that isconfigured to come into contact with right ventricle RV of heart H ofthe patient. Electrode 972A positioned on contact portion 970A will alsocome into contact with right ventricle RV of heart H of the patient.However, 906B has a different shape than prong 106 shown in FIGS. 1-9C.Spring portion 966B and arm portion 968B of prong 906B extend away fromsecond side 912 of housing 902. Contact portion 970B is a portion ofprong 906B adjacent to distal end 962B of prong 906B that is configuredto come into contact with right atrium RA of heart H of the patient.Electrode 972B positioned on contact portion 970B will also come intocontact with right atrium RA of heart H of the patient.

In one example, subcutaneous device 900 can be anchored to xiphoidprocess X and sternum S of a patient. Clip 904 is configured to anchorsubcutaneous device 900 to xiphoid process X and sternum S. Clip 904will expand as it is slid around xiphoid process X and sternum S. Springportion 944 acts as a spring for clip 904 and is under tension. Topportion 940 acts as a tension arm and the forces from spring portion 944translate to and push down on top portion 940. When clip 904 ispositioned on xiphoid process X and sternum S, the tension in springportion 944 will force top portion 940 down onto xiphoid process X andsternum S to anchor clip 904 to xiphoid process X and sternum S.Further, sutures, tines, pins, or screws can be inserted throughopenings 948 on top portion 940 of clip 904 to further anchorsubcutaneous device 900 to xiphoid process X and sternum S.

Subcutaneous device 900 can include a power source, a controller, amemory, a transceiver, sensors, sensing circuitry, therapeuticcircuitry, electrodes, and/or any other component of a medical device.In the embodiment shown in FIGS. 27-28, subcutaneous device 900 isconfigured to be a dual chamber pacemaker. Any one or combination ofelectrode 934, electrode 936, electrode 952, electrode 972A, andelectrode 972B can sense the electrical activity of heart H. The sensedelectrical activity can be transmitted to the sensing circuitry and thecontroller in housing 902 of subcutaneous device 900. The controller candetermine the heart rate of the patient and can detect whether anarrhythmia is present. If an arrhythmia is detected, the controller cansend instructions to therapeutic circuitry to provide a therapeuticelectrical stimulation to heart H. Specifically, a therapeuticelectrical stimulation can be provided to the right ventricle and theright atrium. In this manner, subcutaneous device 900 functions as amonitoring device, a diagnostic device, and a therapeutic device. Inalternate embodiments, subcutaneous device 900 can function only as amonitoring device, a diagnostic device, or a therapeutic device, or anycombinations thereof.

Subcutaneous Device 1000

FIG. 29 is a perspective view of subcutaneous device 1000. Subcutaneousdevice 1000 includes housing 1002, clip 1004, prong 1006A, and prong1006B. Housing 1002 includes first side 1010, second side 1012, top side1014, bottom side 1016, front end 1018, back end 1020, curved surface1022, recess 1024, port 1026A, port 1026B, channel 1028A, channel 1028B,first guide 1030 (not shown in FIG. 29), second guide 1032, electrode1034, and electrode 1036. Clip 1004 includes top portion 1040, bottomportion 1042, spring portion 1044, tip 1046, openings 1048, slot 1050,and electrode 1052. Prong 1006A includes proximal end 1060A (not shownin FIG. 29), distal end 1062A, base portion 1064A, spring portion 1066A,arm portion 1068A, contact portion 1070A, and electrode 1072A. Prong1006B includes proximal end 1060B (not shown in FIG. 29), distal end1062B, base portion 1064B, spring portion 1066B, arm portion 1068B,contact portion 1070B, and electrode 1072B.

Subcutaneous device 1000 includes housing 1002, clip 1004, prong 1006A,and prong 1006B. Housing 1002 has the same general structure and designas housing 102 of subcutaneous device 100 shown in FIGS. 1-9C. However,housing 1002 includes two ports, including port 1026A and port 1026B,and two channels, including channel 1028A and channel 1028B. Thereference numerals that refer to the parts of housing 1002 areincremented by nine-hundred compared to the reference numerals thatrefer to the parts of housing 102 of subcutaneous device 100 shown inFIGS. 1-9C. Port 1026A and port 1026B are positioned next to one anotheron housing 1002, and channel 1028A and channel 1028B are positioned nextto one another on housing 1002. Prong 1006A is configured to beconnected to port 1026A and can be positioned in channel 1028A whensubcutaneous device 1000 is in a stowed position. Prong 1006B isconfigured to be connected to port 1026B and can be positioned inchannel 1028B when subcutaneous device 1000 is in a stowed position.

Clip 1004 has the same general structure and design as clip 104 ofsubcutaneous device 100 shown in FIGS. 1-9C. The reference numerals thatrefer to the parts of clip 1004 are incremented by nine-hundred comparedto the reference numerals that refer to the parts of clip 104 ofsubcutaneous device 100 shown in FIGS. 1-9C.

Prong 1006A and prong 1006B each include the same parts as prong 106 ofsubcutaneous device 100 as shown in FIGS. 1-9C, and the referencenumerals that refer to the parts of prong 1006A and prong 1006B areincremented by nine-hundred compared to the reference numerals thatrefer to the parts of prong 106 of subcutaneous device 100 shown inFIGS. 1-9C. However, prong 1006A and 1006B have a different shape thanprong 106 shown in FIGS. 1-9C. Spring portion 1066A and arm portion1068A of prong 1006A extend away from first side 1010 of housing 1002.Contact portion 1070A is a portion of prong 1006A adjacent to distal end1062A of prong 1006A that is configured to come into contact with theleft ventricle of the patient's heart. Electrode 1072A positioned oncontact portion 1070A will also come into contact with the leftventricle of the patient's heart. Spring portion 1066B and arm portion1068B of prong 1006B extend away from second side 1012 of housing 1002.Contact portion 1070B is a portion of prong 1006B adjacent to distal end1062B of prong 1006B that is configured to come into contact with theright atrium of a patient's heart. Electrode 1072B positioned on contactportion 1070B will also come into contact with the right atrium ofpatient's heart.

In one example, subcutaneous device 1000 can be anchored to a xiphoidprocess and a sternum of a patient. Clip 1004 is configured to anchorsubcutaneous device 1000 to the xiphoid process and the sternum. Clip1004 will expand as it is slid around the xiphoid process and thesternum. Spring portion 1044 acts as a spring for clip 1004 and is undertension. Top portion 1040 acts as a tension arm and the forces fromspring portion 1044 translate to and push down on top portion 1040. Whenclip 1004 is positioned on the xiphoid process and the sternum, thetension in spring portion 1044 will force top portion 1040 down onto thexiphoid process and the sternum to anchor clip 1004 to the xiphoidprocess and the sternum. Further, sutures, tines, pins, or screws can beinserted through openings 1048 on top portion 1040 of clip 1004 tofurther anchor subcutaneous device 1000 to the xiphoid process and thesternum.

Subcutaneous device 1000 can include a power source, a controller, amemory, a transceiver, sensors, sensing circuitry, therapeuticcircuitry, electrodes, and/or any other component of a medical device.In the embodiment shown in FIG. 29, subcutaneous device 1000 isconfigured to be a dual chamber pacemaker. Any one or combination ofelectrode 1034, electrode 1036, electrode 1052, electrode 1072A, andelectrode 1072B can sense the electrical activity of a heart. The sensedelectrical activity can be transmitted to the sensing circuitry and thecontroller in housing 1002 of subcutaneous device 1000. The controllercan determine the heart rate of the patient and can detect whether anarrhythmia is present. If an arrhythmia is detected, the controller cansend instructions to therapeutic circuitry to provide a therapeuticelectrical stimulation to the heart. Specifically, a therapeuticelectrical stimulation can be provided to the left ventricle and theright atrium. In this manner, subcutaneous device 1000 functions as amonitoring device, a diagnostic device, and a therapeutic device. Inalternate embodiments, subcutaneous device 1000 can function only as amonitoring device, a diagnostic device, a therapeutic device, or anycombinations thereof.

Subcutaneous Device 1100

FIG. 30 is a perspective view of subcutaneous device 1100. Subcutaneousdevice 1100 includes housing 1102, clip 1104, prong 1106A, and prong1106B. Housing 1102 includes first side 1110, second side 1112, top side1114, bottom side 1116, front end 1118, back end 1120, curved surface1122, recess 1124, port 1126A, port 1126B, channel 1128A, channel 1128B,first guide 1130 (not shown in FIG. 30), second guide 1132, electrode1134, and electrode 1136. Clip 1104 includes top portion 1140, bottomportion 1142, spring portion 1144, tip 1146, openings 1148, slot 1150,and electrode 1152. Prong 1106A includes proximal end 1160A (not shownin FIG. 30), distal end 1162A, base portion 1164A, spring portion 1166A,arm portion 1168A, contact portion 1170A, and electrode 1172A. Prong1106B includes proximal end 1160B (not shown in FIG. 30), distal end1162B, base portion 1164B, spring portion 1166B, arm portion 1168B,contact portion 1170B, and defibrillator coil 1174B.

Subcutaneous device 1100 includes housing 1102, clip 1104, prong 1106A,and prong 1106B. Housing 1102 has the same general structure and designas housing 102 of subcutaneous device 100 shown in FIGS. 1-9C. However,housing 1102 includes two ports, including port 1126A and port 1126B,and two channels, including channel 1128A and channel 1128B. Thereference numerals that refer to the parts of housing 1102 areincremented by ten-hundred compared to the reference numerals that referto the parts of housing 102 of subcutaneous device 100 shown in FIGS.1-9C. Port 1126A and port 1126B are positioned next to one another onhousing 1102, and channel 1128A and channel 1128B are positioned next toone another on housing 1102. Prong 1106A is configured to be connectedto port 1126A and can be positioned in channel 1128A when subcutaneousdevice 1100 is in a stowed position. Prong 1106B is configured to beconnected to port 1126B and can be positioned in channel 1128B whensubcutaneous device 1100 is in a stowed position.

Clip 1104 has the same general structure and design as clip 104 ofsubcutaneous device 100 shown in FIGS. 1-9C. The reference numerals thatrefer to the parts of clip 1104 are incremented by ten-hundred comparedto the reference numerals that refer to the parts of clip 104 ofsubcutaneous device 100 shown in FIGS. 1-9C.

Prong 1106A and prong 1106B generally include the same parts as prong106 of subcutaneous device 100 as shown in FIGS. 1-9C, and the referencenumerals that refer to the parts of prong 1106A and 1106B areincremented by ten-hundred compared to the reference numerals that referto the parts of prong 106 of subcutaneous device 100 shown in FIGS.1-9C. Prong 1106A has the same shape as prong 106 shown in FIGS. 1-9C.Spring portion 1166A and arm portion 1168A extend away from bottom side1120 of housing 1102. Contact portion 1170A is a portion of prong 1106Aadjacent to distal end 1162A of prong 1106A that is configured to comeinto contact with the right ventricle of the patient's heart. Electrode1172A positioned on contact portion 1170A will also come into contactwith the right ventricle of the patient's heart. However, prong 1106Bhas a different shape than prong 106 shown in FIGS. 1-9C and includesdefibrillator coil 1174B instead of an electrode. Spring portion 1166Band arm portion 1168B extend away from bottom side 1120 of housing 1102.Contact portion 1170B is a portion of prong 1106B adjacent to distal end1162B of prong 1106B that is configured to come into contact with tissueinferior to a patient's heart. Defibrillator coil 1174B is positioned oncontact portion 1170B adjacent to distal end 1162B of prong 1106B. Whenan electrical signal is delivered to defibrillator coil 1174B,defibrillator coil 1174B will create a vector with electrode 1134 onfront end 1118 of housing 1102. In the embodiment shown, defibrillatorcoil 1174B serves as the negative electrode and electrode 1134 serves asthe positive electrode. However, in alternate embodiments this can bereversed. Prong 1106B is positioned so that distal end 1162B, and thuscontact portion 1170B and defibrillator coil 1174B, are positionedinferior to the heart. Thus, the vector created between defibrillatorcoil 1174B and electrode 1134 will pass through a patient's heart toprovide a high voltage electrical shock to the patient's heart.

In one example, subcutaneous device 1100 can be anchored to a xiphoidprocess and a sternum of a patient. Clip 1104 is configured to anchorsubcutaneous device 1100 to the xiphoid process and the sternum. Clip1104 will expand as it is slid around the xiphoid process and thesternum. Spring portion 1144 acts as a spring for clip 1104 and is undertension. Top portion 1140 acts as a tension arm and the forces fromspring portion 1144 translate to and push down on top portion 1140. Whenclip 1104 is positioned on the xiphoid process and the sternum, thetension in spring portion 1144 will force top portion 1140 down onto thexiphoid process and the sternum to anchor clip 1104 to the xiphoidprocess and the sternum. Further, sutures, tines, pins, or screws can beinserted through openings 1148 on top portion 1140 of clip 1104 tofurther anchor subcutaneous device 1100 to the xiphoid process and thesternum.

Subcutaneous device 1100 can include a power source, a controller, amemory, a transceiver, sensors, sensing circuitry, therapeuticcircuitry, electrodes, and/or any other component of a medical device.In the embodiment shown in FIG. 30, subcutaneous device 1100 isconfigured to be a single chamber pacemaker and a defibrillator. Any oneor combination of electrode 1134, electrode 1136, electrode 1152, andelectrode 1172A can sense the electrical activity of a heart. Further,defibrillator coil 1174B can act as an electrode that senses theelectrical activity of the heart. The sensed electrical activity can betransmitted to the sensing circuitry and the controller in housing 1102of subcutaneous device 1100. The controller can determine the heart rateof the patient and can detect whether an arrhythmia or abnormality ispresent. If an arrhythmia is detected, the controller can sendinstructions to therapeutic circuitry to provide a therapeuticstimulation to the heart with electrode 1172A. If an abnormality isdetected, the controller can send instructions to therapeutic circuitryto provide a high voltage electrical shock to the heart withdefibrillator coil 1174B. In this manner, subcutaneous device 1100functions as a monitoring device, a diagnostic device, and a therapeuticdevice. In alternate embodiments, subcutaneous device 1100 can functiononly as a monitoring device, a diagnostic device, or a therapeuticdevice, or any combinations thereof.

Subcutaneous Device 1200

FIG. 31A is a perspective view of subcutaneous device 1200. FIG. 31B isa side view of subcutaneous device 1200. FIG. 31C is a top view ofsubcutaneous device 1200. FIG. 31D is a front view of subcutaneousdevice 1200. FIG. 31E is a back view of subcutaneous device 1200. FIG.32A is a cut-away perspective view of subcutaneous device 1200positioned on xiphoid process X and sternum S and showing a positioningof prongs 1206A, 1206B, and 1206C on heart H. FIG. 32B is a cut-awayfront view of subcutaneous device 1200 positioned on xiphoid process Xand sternum S and showing a positioning of 1206A, 1206B, and 1206C onheart H. FIG. 32C is a cut-away front view of subcutaneous device 1200positioned on xiphoid process X and sternum S and showing a positioningof prongs 1206A, 1206B, and 1206C on heart H. Subcutaneous device 1200includes housing 1202, clip 1204, prong 1206A, prong 1206B, and prong1206C. Housing 1202 includes first side 1210, second side 1212, top side1214, bottom side 1216, front end 1218, back end 1220, curved surface1222, recess 1224, port 1226A, port 1226B, port 1226C, channel 1228A,channel 1228B, channel 1228C, first guide 1230, second guide 1232,electrode 1234, and electrode 1236. Clip 1204 includes top portion 1240,bottom portion 1242, spring portion 1244, tip 1246, openings 1248, slot1250, and electrode 1252. Prong 1206A includes proximal end 1260A (notshown in FIGS. 31A-32C), distal end 1262A, base portion 1264A, springportion 1266A, arm portion 1268A, contact portion 1270A, and electrode1272A. Prong 1206B includes proximal end 1260B (not shown in FIGS.31A-32C), distal end 1262B, base portion 1264B, spring portion 1266B,arm portion 1268B, contact portion 1270B, and electrode 1272B. Prong1206C includes proximal end 1260C (not shown in FIGS. 31A-32C), distalend 1262C, base portion 1264C, spring portion 1266C, arm portion 1268C,contact portion 1270C, and electrode 1272C. FIGS. 32A-32C includexiphoid process X, sternum S, heart H, left ventricle LV, rightventricle RV, and right atrium RA. FIG. 32C also show ribs R.

Subcutaneous device 1200 includes housing 1202, clip 1204, prong 1206A,prong 1206B, and prong 1206C. Housing 1202 has the same generalstructure and design as housing 102 of subcutaneous device 100 shown inFIGS. 1-9C. However, housing 1202 includes three ports, including port1226A, port 1226B, and port 1226C, and three channels, including channel1228A, channel 1228B, and channel 1228C. The reference numerals thatrefer to the parts of housing 1202 are incremented by eleven-hundredcompared to the reference numerals that refer to the parts of housing102 of subcutaneous device 100 shown in FIGS. 1-9C. Port 1226A, port1226B, and port 1228C are positioned next to one another on housing1202, and channel 1228A, channel 1228B, and channel 1228C are positionednext to one another on housing 1202. Prong 1206A is configured to beconnected to port 1226A and can be positioned in channel 1228A whensubcutaneous device 1200 is in a stowed position. Prong 1206B isconfigured to be connected to port 1226B and can be positioned inchannel 1228B when subcutaneous device 1200 is in a stowed position.Prong 1206C is configured to be connected to port 1226C and can bepositioned in channel 1228C when subcutaneous device 1200 is in a stowedposition.

Clip 1204 has the same general structure and design as clip 104 ofsubcutaneous device 100 shown in FIGS. 1-9C. The reference numerals thatrefer to the parts of clip 1204 are incremented by eleven-hundredcompared to the reference numerals that refer to the parts of clip 104of subcutaneous device 100 shown in FIGS. 1-9C.

Prong 1206A, prong 1206B, and prong 1206C each include the same parts asprong 106 of subcutaneous device 100 as shown in FIGS. 1-9C, and thereference numerals that refer to the parts of prong 1206A, prong 1206B,and prong 1206C are incremented by eleven-hundred compared to thereference numerals that refer to the parts of prong 106 of subcutaneousdevice 100 shown in FIGS. 1-9C. However, prong 1206A and prong 1206Chave a different shape than prong 106 shown in FIGS. 1-9C. Springportion 1266A and arm portion 1268A of prong 1206A extend away fromfirst side 1210 of housing 1202. Contact portion 1270A is a portion ofprong 1206A adjacent to distal end 1262A of prong 1206A that isconfigured to come into contact with left ventricle LV of heart H of thepatient. Electrode 1272A positioned on contact portion 1270A will alsocome into contact with left ventricle LV of heart H of the patient.Spring portion 1266C and arm portion 1268C of prong 1206C extend awayfrom second side 1212 of housing 1202. Contact portion 1270C is aportion of prong 1206C adjacent to distal end 1262C of prong 1206C thatis configured to come into contact with right atrium RA of heart H ofthe patient. Electrode 1272C positioned on contact portion 1270C willalso come into contact with right atrium RA of heart H of the patient.Prong 1206B has the same shape as prong 106 shown in FIGS. 1-9C. Springportion 1266B and arm portion 1268B of prong 1206B extend underneathbottom side 1216 of housing 1202. Contact portion 1270B is a portion ofprong 1206B adjacent to distal end 1262B of prong 1206B that isconfigured to come into contact with right ventricle RV of heart H ofthe patient. Electrode 1272B positioned on contact portion 1270B willalso come into contact with right ventricle RV of heart H of thepatient.

In one example, subcutaneous device 1200 can be anchored to xiphoidprocess X and sternum S of a patient. Clip 1204 is configured to anchorsubcutaneous device 1200 to xiphoid process X and sternum S. Clip 1204will expand as it is slid around xiphoid process X and sternum S. Springportion 1244 acts as a spring for clip 1204 and is under tension. Topportion 1240 acts as a tension arm and the forces from spring portion1244 translate to and push down on top portion 1240. When clip 1204 ispositioned on xiphoid process X and sternum S, the tension in springportion 1244 will force top portion 1240 down onto xiphoid process X andsternum S to anchor clip 1204 to xiphoid process X and sternum S.Further, sutures, tines, pins, or screws can be inserted throughopenings 1248 on top portion 1240 of clip 1204 to further anchorsubcutaneous device 1200 to xiphoid process S and sternum S.

Subcutaneous device 1200 can include a power source, a controller, amemory, a transceiver, sensors, sensing circuitry, therapeuticcircuitry, electrodes, and/or any other component of a medical device.In the embodiment shown in FIGS. 31A-32C, subcutaneous device 1200 isconfigured to be a triple chamber pacemaker. Any one or combination ofelectrode 1234, electrode 1236, electrode 1252, electrode 1272A,electrode 1274B, and electrode 1274C can sense the electrical activityof heart H. The sensed electrical activity can be transmitted to thesensing circuitry and the controller in housing 1202 of subcutaneousdevice 1200. The controller can determine the heart rate of the patientand can detect whether an arrhythmia is present. If an arrhythmia isdetected, the controller can send instructions to therapeutic circuitryto provide a therapeutic electrical stimulation to heart H.Specifically, a therapeutic electrical stimulation can be provided tothe right ventricle, the left ventricle, and the right atrium. In thismanner, subcutaneous device 1200 functions as a monitoring device, adiagnostic device, and a therapeutic device. In alternate embodiments,subcutaneous device 1200 can function only as a monitoring device, adiagnostic device, or a therapeutic device, or any combinations thereof.

Subcutaneous Device 1300

FIG. 33 is a perspective view of subcutaneous device 1300. Subcutaneousdevice 1300 includes housing 1302, clip 1304, prong 1306A, prong 1306B,and prong 1306C. Housing 1302 includes first side 1310, second side1312, top side 1314, bottom side 1316, front end 1318, back end 1320,curved surface 1322, recess 1324, port 1326A, port 1326B, port 1326C,channel 1328A (not shown in FIG. 33), channel 1328B, channel 1328C,first guide 1330 (not shown in FIG. 33), second guide 1332, electrode1334, and electrode 1336. Clip 1304 includes top portion 1340, bottomportion 1342, spring portion 1344, tip 1346, openings 1348, slot 1350,and electrode 1352. Prong 1306A includes proximal end 1360A (not shownin FIG. 33), distal end 1362A, base portion 1364A, spring portion 1366A,arm portion 1368A, contact portion 1370A, and electrode 1372A. Prong1306B includes proximal end 1360B (not shown in FIG. 33), distal end1362B, base portion 1364B, spring portion 1366B, arm portion 1368B,contact portion 1370B, and electrode 1372B. Prong 1306C includesproximal end 1360C (not shown in FIG. 33), distal end 1362C, baseportion 1364C, spring portion 1366C, arm portion 1368C, contact portion1370C, and defibrillator coil 1374C.

Subcutaneous device 1300 includes housing 1302, clip 1304, prong 1306A,prong 1306B, and prong 1306C. Housing 1302 has the same generalstructure and design as housing 102 of subcutaneous device 100 shown inFIGS. 1-9C. However, housing 1302 includes three ports, including port1326A, port 1326B, and port 1326C, and three channels, including channel1328A, channel 1328B, and channel 1328C. The reference numerals thatrefer to the parts of housing 1302 are incremented by twelve-hundredcompared to the reference numerals that refer to the parts of housing102 of subcutaneous device 100 shown in FIGS. 1-9C. Port 1326A, port1326B, and port 1326C are positioned next to one another on housing1302, and channel 1328A, channel 1328B, and channel 1328C are positionednext to one another on housing 1302. Prong 1306A is configured to beconnected to port 1326A and can be positioned in channel 1328A whensubcutaneous device 1300 is in a stowed position. Prong 1306B isconfigured to be connected to port 1326B and can be positioned inchannel 1328B when subcutaneous device 1300 is in a stowed position.Prong 1306C is configured to be connected to port 1326C and can bepositioned in channel 1328C when subcutaneous device 1300 is in a stowedposition.

Clip 1304 has the same general structure and design as clip 104 ofsubcutaneous device 100 shown in FIGS. 1-9C. The reference numerals thatrefer to the parts of clip 1304 are incremented by twelve-hundredcompared to the reference numerals that refer to the parts of clip 104of subcutaneous device 100 shown in FIGS. 1-9C.

Prong 1306A, prong 1306B, and prong 1306C generally include the sameparts as prong 106 of subcutaneous device 100 as shown in FIGS. 1-9C,and the reference numerals that refer to the parts of prong 1306A, prong1306B, and prong 1306C are incremented by twelve-hundred compared to thereference numerals that refer to the parts of prong 106 of subcutaneousdevice 100 shown in FIGS. 1-9C. However, prong 1306A and prong 1306Chave a different shape than prong 106 shown in FIGS. 1-9C, and prong1306C includes defibrillator coil 1374C instead of an electrode. Springportion 1366A and arm portion 1368A extend away from first side 1310 ofhousing 1302. Contact portion 1370A is a portion of prong 1306A adjacentto distal end 1362A of prong 1306A that is configured to come intocontact with the left ventricle of the patient's heart. Electrode 1372Apositioned on contact portion 1370A will also come into contact with theleft ventricle of the patient's heart. Spring portion 1366C and armportion 1368C extend away from bottom side 1320 of housing 1302. Contactportion 1370C is a portion of prong 1306C adjacent to distal end 1362Cof prong 1306C that is configured to come into contact with tissueinferior to a patient's heart. Defibrillator coil 1374C is positioned oncontact portion 1370C adjacent to distal end 1362C of prong 1306C. Whenan electrical signal is delivered to defibrillator coil 1374C,defibrillator coil 1374C will create a vector with electrode 1334 onfront end 1318 of housing 1302. In the embodiment shown, defibrillatorcoil 1374C serves as the negative electrode and electrode 1334 serves asthe positive electrode. However, in alternate embodiments this can bereversed. Prong 1306C is positioned so that distal end 1362C, and thuscontact portion 1370C and defibrillator coil 1374C, are positionedinferior to the heart. Thus, the vector created between defibrillatorcoil 1374C and electrode 1334 will pass through a patient's heart toprovide a high voltage electrical shock to the patient's heart. Prong1306B has the same shape as prong 106 shown in FIGS. 1-9C. Springportion 1366B and arm portion 1368B extend away from bottom side 1320 ofhousing 1302. Contact portion 1370B is a portion of prong 1306B adjacentto distal end 1362B of prong 1306B that is configured to come intocontact with the left ventricle of the patient's heart. Electrode 1372Bpositioned on contact portion 1370B will also come into contact with theleft ventricle of the patient's heart.

In one example, subcutaneous device 1300 can be anchored to a xiphoidprocess and a sternum of a patient. Clip 1304 is configured to anchorsubcutaneous device 1300 to the xiphoid process and the sternum. Clip1304 will expand as it is slid around the xiphoid process and thesternum. Spring portion 1344 acts as a spring for clip 1304 and is undertension. Top portion 1340 acts as a tension arm and the forces fromspring portion 1344 translate to and push down on top portion 1340. Whenclip 1304 is positioned on the xiphoid process and the sternum, thetension in spring portion 1344 will force top portion 1340 down onto thexiphoid process and the sternum to anchor clip 1304 to the xiphoidprocess and the sternum. Further, sutures, tines, pins, or screws can beinserted through openings 1348 on top portion 1340 of clip 1304 tofurther anchor subcutaneous device 1300 to the xiphoid process and thesternum.

Subcutaneous device 1300 can include a power source, a controller, amemory, a transceiver, sensors, sensing circuitry, therapeuticcircuitry, electrodes, and/or any other component of a medical device.In the embodiment shown in FIG. 33, subcutaneous device 1300 isconfigured to be a two chamber pacemaker and a defibrillator. Any one orcombination of electrode 1334, electrode 1336, electrode 1352, electrode1372A, and electrode 1372B can sense the electrical activity of a heart.Further, defibrillator coil 1374C can act as an electrode that sensesthe electrical activity of the heart. The sensed electrical activity canbe transmitted to the sensing circuitry and the controller in housing1302 of subcutaneous device 1300. The controller can determine the heartrate of the patient and can detect whether an arrhythmia or anabnormality is present. If an arrhythmia is detected, the controller cansend instructions to therapeutic circuitry to provide a therapeuticelectrical stimulation to the heart with electrode 1372A and electrode137B. Specifically, a therapeutic electrical stimulation can be providedto the right ventricle and the left ventricle. If an abnormality isdetected, the controller can send instructions to therapeutic circuitryto provide a high voltage electrical shock to the heart withdefibrillator coil 1374C. In this manner, subcutaneous device 1300functions as a monitoring device, a diagnostic device, and a therapeuticdevice. In alternate embodiments, subcutaneous device 1300 can functiononly as a monitoring device, a diagnostic device, or a therapeuticdevice, or any combinations thereof.

Subcutaneous Device 1400

FIG. 34A is a perspective view of subcutaneous device 1400. FIG. 34B isa perspective view of subcutaneous device 1400. FIG. 34C is a side viewof subcutaneous device 1400. Subcutaneous device 1400 includes housing1402, clip 1404, prong 1406A, prong 1406B, prong 1406C, and prong 1406D.Housing 1402 includes first side 1410, second side 1412, top side 1414,bottom side 1416, front end 1418, back end 1420, curved surface 1422,recess 1424, port 1426A, port 1426B, port 1426C, port 1426D, channel1428A (not shown in FIGS. 34A-34C), channel 1428B, channel 1428C,channel 1428D, first guide 1430, second guide 1432, electrode 1434, andelectrode 1436. Clip 1404 includes top portion 1440, bottom portion1442, spring portion 1444, tip 1446, openings 1448, slot 1450, andelectrode 1452. Prong 1406A includes proximal end 1460A (not shown inFIGS. 34A-34C), distal end 1462A, base portion 1464A, spring portion1466A, arm portion 1468A, contact portion 1470A, and defibrillator coil1474A. Prong 1406B includes proximal end 1460B (not shown in FIGS.34A-34C), distal end 1462B, base portion 1464B, spring portion 1466B,arm portion 1468B, contact portion 1470B, and defibrillator coil 1474B.Prong 1406C includes proximal end 1460C (not shown in FIGS. 34A-34C),distal end 1462C, base portion 1464C, spring portion 1466C, arm portion1468C, contact portion 1470C, and electrode 1474C. Prong 1406D includesproximal end 1460D (not shown in FIGS. 34A-34C), distal end 1462D, baseportion 1464D, spring portion 1466D, arm portion 1468D, contact portion1470D, and defibrillator coil 1474D.

Subcutaneous device 1400 includes housing 1402, clip 1404, prong 1406A,prong 1406B, prong 1406C, and prong 1406D. Housing 1402 has the samegeneral structure and design as housing 102 of subcutaneous device 100shown in FIGS. 1-9C. However, housing 1402 includes four ports,including port 1426A, port 1426B, port 1426C, and port 1426D, and fourchannels, including channel 1428A, channel 1428B, channel 1428C, andchannel 1428D. The reference numerals that refer to the parts of housing1402 are incremented by thirteen-hundred compared to the referencenumerals that refer to the parts of housing 102 of subcutaneous device100 shown in FIGS. 1-9C. Port 1426A, port 1426B, port 1426C, and port1426D are positioned next to one another on housing 1402, and channel1428A, channel 1428B, channel 1428C, and channel 1428D are positionednext to one another on housing 1402. Prong 1406A is configured to beconnected to port 1426A and can be positioned in channel 1428A whensubcutaneous device 1400 is in a stowed position. Prong 1406B isconfigured to be connected to port 1426B and can be positioned inchannel 1428B when subcutaneous device 1400 is in a stowed position.Prong 1406C is configured to be connected to port 1426C and can bepositioned in channel 1428C when subcutaneous device 1400 is in a stowedposition. Prong 1406D is configured to be connected to port 1426D andcan be positioned in channel 1428D when subcutaneous device 1400 is in astowed position.

Clip 1404 has the same general structure and design as clip 104 ofsubcutaneous device 100 shown in FIGS. 1-9C. The reference numerals thatrefer to the parts of clip 1404 are incremented by thirteen-hundredcompared to the reference numerals that refer to the parts of clip 104of subcutaneous device 100 shown in FIGS. 1-9C.

Prong 1406A, prong 1406B, prong 1406C, and prong 1406D generally includethe same parts as prong 106 of subcutaneous device 100 as shown in FIGS.1-9C, and the reference numerals that refer to the parts of prong 1406A,prong 1406B, prong 1406C, and prong 1406D are incremented bythirteen-hundred compared to the reference numerals that refer to theparts of prong 106 of subcutaneous device 100 shown in FIGS. 1-9C.However, prong 1406A, prong 1406B, and prong 1406D have a differentshape than prong 106 shown in FIGS. 1-9C and include defibrillator coil1474A, defibrillator coil 1474B, and defibrillator coil 1474D,respectively, instead of an electrode.

Spring portion 1466A and arm portion 1468A extend along first side 1410of housing 1402. Contact portion 1470A is a portion of prong 1406Aadjacent to distal end 1462A of prong 1406A that is configured to comeinto contact with tissue on first side 1410 of housing 1402.Defibrillator coil 1474A is positioned on contact portion 1470A adjacentto distal end 1462A of prong 1406A. Defibrillator coil 1474A isconfigured to create a vector with defibrillator coil 1474B. Springportion 1466D and arm portion 1468D extend along second side 1412 ofhousing 1402. Contact portion 1470D is a portion of prong 1406D adjacentto distal end 1462D of prong 1406D that is configured to come intocontact with tissue on second side 1412 of housing 1402. Defibrillatorcoil 1474D is positioned on contact portion 1470D adjacent to distal end1462D of prong 1406D. Defibrillator coil 1474D is configured to create avector with defibrillator coil 1474B.

Spring portion 1466B and arm portion 1468B extend away from bottom side1420 of housing 1402. Contact portion 1470B is a portion of prong 1406Badjacent to distal end 1462B of prong 1406B that is configured to comeinto contact with tissue inferior to a patient's heart. Defibrillatorcoil 1474B is positioned on contact portion 1470B adjacent to distal end1462B of prong 1406B. When an electrical signal is delivered todefibrillator coil 1474B, defibrillator coil 1474B will create a firstvector with electrode 1434 on front end 1418 of housing 1402, a secondvector with defibrillator coil 1474A on prong 1406A, and a third vectorwith defibrillator coil 1474D on prong 1406D. In the embodiment shown,defibrillator coil 1474B serves as the negative electrode and electrode1434, defibrillator coil 1474A, and defibrillator coil 1474D serve asthe positive electrodes. However, in alternate embodiments this can bereversed. Prong 1406B is positioned so that distal end 1462B, and thuscontact portion 1470B and defibrillator coil 1474B, are positionedinferior to the heart. Thus, the vectors created between defibrillatorcoil 1474B and electrode 1434, defibrillator coil 1474A, anddefibrillator coil 1474D will pass through a patient's heart to providea high voltage electrical shock to the patient's heart.

Prong 1406C has the same shape as prong 106 shown in FIGS. 1-9C. Springportion 1466C and arm portion 1468C extend away from bottom side 1420 ofhousing 1402. Contact portion 1470C is a portion of prong 1406C adjacentto distal end 1462C of prong 1406C that is configured to come intocontact with the left ventricle of the patient's heart. Electrode 1472Cpositioned on contact portion 1470C will also come into contact with theleft ventricle of the patient's heart.

In one example, subcutaneous device 1400 can be anchored to a xiphoidprocess and a sternum of a patient. Clip 1404 is configured to anchorsubcutaneous device 1400 to the xiphoid process and the sternum. Clip1404 will expand as it is slid around the xiphoid process and thesternum. Spring portion 1444 acts as a spring for clip 1404 and is undertension. Top portion 1440 acts as a tension arm and the forces fromspring portion 1444 translate to and push down on top portion 1440. Whenclip 1404 is positioned on the xiphoid process and the sternum, thetension in spring portion 1444 will force top portion 1440 down onto thexiphoid process and the sternum to anchor clip 1404 to the xiphoidprocess and the sternum. Further, sutures, tines, pins, or screws can beinserted through openings 1448 on top portion 1440 of clip 1404 tofurther anchor subcutaneous device 1400 to the xiphoid process and thesternum.

Subcutaneous device 1400 can include a power source, a controller, amemory, a transceiver, sensors, sensing circuitry, therapeuticcircuitry, electrodes, and/or any other component of a medical device.In the embodiment shown in FIGS. 34A-34C, subcutaneous device 1400 isconfigured to be a single chamber pacemaker and a multi-vectordefibrillator. Any one or combination of electrode 1434, electrode 1436,electrode 1452, and electrode 1472C can sense the electrical activity ofa heart. Further, defibrillator coil 1474A, defibrillator coil 1474B,and defibrillator coil 1474D can act as an electrode that senses theelectrical activity of the heart. The sensed electrical activity can betransmitted to the sensing circuitry and the controller in housing 1402of subcutaneous device 1400. The controller can determine the heart rateof the patient and can detect whether an arrhythmia or abnormality ispresent. If an arrhythmia is detected, the controller can sendinstructions to therapeutic circuitry to provide a therapeuticelectrical shock to the heart with electrode 1472C. If an abnormality isdetected, the controller can send instructions to therapeutic circuitryto provide a high voltage electrical shock to the heart withdefibrillator coil 1474B. In this manner, subcutaneous device 1400functions as a monitoring device, a diagnostic device, and a therapeuticdevice. In alternate embodiments, subcutaneous device 1400 can functiononly as a monitoring device, a diagnostic device, a therapeutic device,or any combinations thereof.

Subcutaneous Device 1500

FIG. 35A is a perspective view of subcutaneous device 1500. FIG. 35B isa perspective view of subcutaneous device 1500. FIG. 35C is a bottomview of subcutaneous device 1500. FIG. 35D is a side view ofsubcutaneous device 1500. FIG. 35E is a back view of subcutaneous device1500. FIG. 35F is a front view of subcutaneous device 1500. FIG. 36A isa schematic diagram of subcutaneous device 1500. FIG. 36B is a sectionaldiagram illustrating portions of subcutaneous device 1500 from the side.FIG. 36C is a sectional diagram illustrating portions of subcutaneousdevice 1500 from the bottom. FIG. 37 is a perspective view ofsubcutaneous device 1500 positioned on xiphoid process X and sternum S.Subcutaneous device 1500 includes housing 1502, clip 1504, prong 1506A,and prong 1506B. Housing 1502 includes first side 1510, second side1512, top side 1514, bottom side 1516, front end 1518, back end 1520,curved surface 1522, recess 1524, port 1526A, port 1526B, first guide1530, second guide 1532, electrode 1534, and electrode 1536. Clip 1504includes top portion 1540, bottom portion 1542, spring portion 1544, tip1546, openings 1548, slot 1550, and electrode 1552. Prong 1506A includesproximal end 1560A, distal end 1562A, base portion 1564A, spring portion1566A, arm portion 1568A, contact portion 1570A, opening 1576A, andlumen 1578A. Prong 1508B includes proximal end 1560B, distal end 1562B,base portion 1564B, spring portion 1566B, arm portion 1568B, opening1576B, and lumen 1578B. Subcutaneous device 1500 further includes drugreservoir 1580, drug pump 1582, fluid connector 1584, fluid connector1586, fluid connector 1588, electronic components 1590, and battery1592. FIG. 37 shows xiphoid process X and sternum S.

Subcutaneous device 1500 includes housing 1502, clip 1504, prong 1506A,and prong 1506B. Housing 1502 has the same general structure and designas housing 102 of subcutaneous device 100 shown in FIGS. 1-9C. However,housing 1502 includes two ports, including port 1526A and port 1526B.The reference numerals that refer to the parts of housing 1502 areincremented by fourteen-hundred compared to the reference numerals thatrefer to the parts of housing 102 of subcutaneous device 100 shown inFIGS. 1-9C. Port 1526A and port 1526B are positioned next to one anotheron housing 1502. Prong 1506A is configured to be connected to port1526A. Prong 1506B is configured to be connected to port 1526B.

Clip 1504 has the same general structure and design as clip 104 ofsubcutaneous device 100 shown in FIGS. 1-9C. The reference numerals thatrefer to the parts of clip 1504 are incremented by fourteen-hundredcompared to the reference numerals that refer to the parts of clip 104of subcutaneous device 100 shown in FIGS. 1-9C.

Prong 1506A and prong 1506B generally include the same parts as prong106 of subcutaneous device 100 as shown in FIGS. 1-9C, and the referencenumerals that refer to the parts of prong 1506A and prong 1506B areincremented by fourteen-hundred compared to the reference numerals thatrefer to the parts of prong 106 of subcutaneous device 100 shown inFIGS. 1-9C. However, prong 1506A and prong 1506B have a different shapethan prong 106 shown in FIGS. 1-9C, and include opening 1576A and lumen1578A, and opening 1576B and lumen 1578B, respectively. Spring portion1566A and arm portion 1568A extend underneath bottom side 1516 ofhousing 1502. Contact portion 1570A is a portion of prong 1506A adjacentto distal end 1562A of prong 1506A that is configured to come intocontact with an organ, a nerve, or a tissue. Prong 1506A has opening1576A at distal end 1562A and includes lumen 1578A extending fromproximal end 1560A to distal end 1562A. Spring portion 1566B and armportion 1568B extend upwards along back side 1520 of housing 1502. Prong1506B has opening 1576B at distal end 1562B and includes lumen 1578Bextending from proximal end 1560B to distal end 1562B.

In one example, subcutaneous device 1500 can be anchored to xiphoidprocess X and sternum S of a patient. Clip 1504 is configured to anchorsubcutaneous device 1500 to xiphoid process X and sternum S. Clip 1504will expand as it is slid around xiphoid process X and sternum S. Springportion 1544 acts as a spring for clip 1504 and is under tension. Topportion 1540 acts as a tension arm and the forces from spring portion1544 translate to and push down on top portion 1540. When clip 1504 ispositioned on xiphoid process X and sternum S, the tension in springportion 1544 will force top portion 1540 down onto xiphoid process X andsternum S to anchor clip 1504 to xiphoid process X and sternum S.Further, sutures, tines, pins, or screws can be inserted throughopenings 1548 on top portion 1540 of clip 1504 to further anchorsubcutaneous device 1500 to xiphoid process X and sternum S.

Subcutaneous device 1500 can include a power source, a controller, amemory, a transceiver, sensors, sensing circuitry, therapeuticcircuitry, electrodes, and/or any other component of a medical device.In the embodiment shown in FIGS. 35A-37, subcutaneous device 1500 isconfigured to be a drug delivery device. As shown in FIGS. 36A-36C,subcutaneous device 1500 includes drug reservoir 1580 and drug pump 1582positioned in housing 1502. Drug reservoir 1580 includes fluid connector1584 that fluidly connects drug reservoir 1580 to prong 1506B and fluidconnector 1586 that fluidly connects drug reservoir 1580 to drug pump1582. Drug pump 1582 also includes fluid connector 1588 that fluidlyconnects drug pump 1582 to prong 1506A. A drug can be inserted intoopening 1576B of prong 1506B and then travel through lumen 1578B ofprong 1506B to drug reservoir 1580. In this way, drug reservoir 1580 canbe replenished and refilled as needed. An injector can be positioned inopening 1578B to inject the drug into prong 1506B. The drug in drugreservoir 1580 can then be pumped out of drug reservoir 1580 with drugpump 1582. Drug pump 1582 will pump the drug in drug reservoir 1580through fluid connector 1586, drug pump 1582, fluid connector 1588, andinto prong 1506A. The drug in prong 1506A can travel through lumen 1578Aof prong 1506A and exit prong 1506A at opening 1576A. Opening 1576A ispositioned to contact an organ, a nerve, or a tissue, so the drug can beapplied to the organ, the nerve, or the tissue. FIGS. 36A-36C also showelectronic components 1590, which can include a controller, a memory, atransceiver, sensors, sensing circuitry, therapeutic circuitry,electrodes, and/or any other component of a medical device, and battery1592. Battery 1592 powers subcutaneous device 1500, including electroniccomponents 1590 and drug pump 1592. Electronic components 1590 canspecifically include therapeutic circuitry that can send a signal todrug pump 1592 to administer a drug to the patient through prong 1506A.In this manner, subcutaneous device 1500 functions as a drug deliverydevice that is capable of providing a targeted or systemic therapeuticdrug to an organ, a nerve, or a tissue. Providing a targeted or systemictherapeutic drug can be used to treat cancer, diabetes, andhypertension. Treating cancer with targeted or systemic therapeutic drugcan reduce side effects. In alternate embodiments, subcutaneous device1500 can include components to allow it to also function as a monitoringand diagnostic device, as a pacemaker device, or as a defibrillatordevice.

Subcutaneous devices 100, 400, 500, 600, 700, 800, 900, 1000, 1100,1200, 1300, 1400, and 1500 disclose various embodiments of thesubcutaneous devices, including: a single prong cardiac monitoringdevice, a multi-prong cardiac monitoring device, a pulmonary monitoringdevice, a single chamber pacemaker, a dual chamber pacemaker, a triplechamber pacemaker, an atrial defibrillator, a single-vector ventriculardefibrillator, a multi-vector ventricular defibrillator, and animplantable drug pump and/or drug delivery device. Each of the pacemakerembodiments can also function as a monitoring and diagnostic deviceand/or a drug delivery device; each of the defibrillator embodiments canalso function as a monitoring and diagnostic device, a pacemaker device,and/or a drug delivery device; and each of the drug delivery embodimentscan also function as a monitoring and diagnostic device, a pacemakerdevice, and/or a defibrillator device. Further, the features of eachembodiment may be combined and/or substituted with features of any otherembodiment, unless explicitly disclosed otherwise.

Discussion of Possible Embodiments

The following are non-exclusive descriptions of possible embodiments ofthe present invention.

A subcutaneously implantable device includes a housing, a clip attachedto a top side of the housing, and an electrode. The clip is configuredto anchor the device to a muscle, a bone, and/or a first tissue. Theelectrode is configured to contact an organ, a nerve, the first tissue,and/or a second tissue. Circuitry in the housing is in electricalcommunication with the electrode that is configured to sense anelectrical signal from the organ, the nerve, the first tissue, and/orthe second tissue through the electrode; deliver electrical stimulationto the organ, the nerve, the first tissue, and/or the second tissuethrough the electrode; and/or deliver a signal to a drug pump to providea targeted or systemic therapeutic drug to the organ, the nerve, thefirst tissue, and/or the second tissue.

The device of the preceding paragraph can optionally include,additionally and/or alternatively, any one or more of the followingfeatures, configurations and/or additional components:

Wherein the clip is configured to attach the device to a xiphoid processand/or a sternum of a patient.

Wherein the clip is configured with respect to the housing such thatwhen the clip is attached to the xiphoid process and/or the sternum, thehousing of the device is positioned below the xiphoid process and/or thesternum of the patient.

Wherein the electrode is positioned on the housing.

Wherein the housing further includes a recess on a top side of thehousing, wherein the clip is positioned in the recess.

Wherein the clip is welded to the top side of the housing.

Wherein the clip includes a top portion, a bottom portion, and a springportion extending between and connecting the top portion to the bottomportion.

Wherein the electrode is positioned on the top portion of the clip.

Wherein the spring portion is curved and is configured to act as aspring for the clip to push the top portion of the clip onto the bone,the muscle, and/or the first tissue to which it is anchored.

Wherein the clip further includes a first opening and a second openingextending through the top portion of the clip, wherein the first openingand the second opening are configured to receive sutures, tines, pins,or screws to secure the device to the bone, the muscle, and/or the firsttissue on which the clip is anchored.

The device further includes a prong with a proximal end attached to thehousing and a distal end extending away from the housing that isconfigured to contact the organ, the nerve, and/or the second tissue,wherein the electrode is positioned on the distal end of the prong.

Wherein the housing further includes a channel on the bottom side of thehousing extending from a back end to a front end of the housing, whereinwhen the device is in a stowed position, the prong is positioned in thechannel.

Wherein the prong further includes a base portion on the proximal end ofthe prong; a spring portion extending from the base portion; an armportion extending from the spring portion; and a contact portionextending from the arm portion and terminating at the distal end of theprong.

Wherein the housing further includes a port on a back side of thehousing, wherein the base portion of the prong is positioned in theport.

Wherein the spring portion is curved and is configured to act as aspring for the prong.

Wherein the electrode is positioned on the contact portion of the prong.

Wherein a lumen extending from the proximal end to the distal end of theprong is configured to provide the targeted or systemic therapeutic drugto the organ, the nerve, and/or the second tissue with which the distalend of the prong is in contact with.

A subcutaneously implantable device includes a housing, a clip attachedto a top side of the housing, a prong with a proximal end attached tothe housing and a distal end extending away from the housing that, andan electrode. The clip is configured to anchor the device to a muscle, abone, and/or a first tissue. The prong is configured to contact anorgan, a nerve, and/or a second tissue. The electrode is configured tocontact the organ, the nerve, the first tissue, and/or the secondtissue. Circuitry in the housing is in electrical communication with theelectrode that is configured to sense an electrical signal from theorgan, the nerve, the first tissue, and/or the second tissue through theelectrode; deliver electrical stimulation to the organ, the nerve, thefirst tissue, and/or the second tissue through the electrode; and/ordeliver a signal to a drug pump to provide a targeted or systemictherapeutic drug to the organ, the nerve, the first tissue, and/or thesecond tissue.

The device of the preceding paragraph can optionally include,additionally and/or alternatively, any one or more of the followingfeatures, configurations and/or additional components:

Wherein the clip is configured to attach the device to a xiphoid processand/or a sternum of a patient.

Wherein the clip is configured with respect to the housing such thatwhen the clip is attached to the xiphoid process and/or the sternum, thehousing of the device is positioned below the xiphoid process and/or thesternum of the patient.

Wherein the clip further includes a top portion, a bottom portion, and aspring portion extending between and connecting the top portion to thebottom portion.

Wherein the spring portion is curved and is configured to act as aspring for the clip to push the top portion of the clip onto the bone,the muscle, and/or the first tissue to which it is anchored.

Wherein the clip further includes a first opening and a second openingextending through the top portion of the clip, wherein the first openingand the second opening are configured to receive sutures, tines, pins,or screws to secure the device to the bone, the muscle, and/or the firsttissue on which the clip is anchored.

Wherein the prong further includes a base portion on a proximal end ofthe prong; a spring portion extending from the base portion; an armportion extending from the spring portion; and a contact portionextending form the arm portion and terminating at a distal end of theprong.

Wherein the housing further includes a port on a back side of thehousing, wherein the base portion of the prong is positioned in theport.

Wherein the spring portion is curved and is configured to act as aspring for the prong.

Wherein the electrode is positioned on the contact portion of the prong.

Wherein the electrode is configured to come into contact with a heart.

Wherein the electrode is configured to provide therapeutic stimulationto the heart.

Wherein a lumen extending from the proximal end to the distal end of theprong is configured to provide the targeted or systemic therapeutic drugto the organ, the nerve, and/or the second tissue with which the distalend of the prong is in contact with.

A method of subcutaneously injecting and anchoring a device to a bone, amuscle, and/or a tissue in a patient, the device having a clipconfigured to anchor the device to the bone, the muscle, or the tissue,includes making an incision in the patient. An instrument pre-loadedwith the device is inserted through the incision. The instrument isadvanced to the bone, the muscle, and/or the tissue upon which thedevice is to be anchored. A clip of the device is pushed onto the bone,the muscle, and/or the tissue using the instrument. The device isanchored to the bone, the muscle, and/or the tissue using the clip onthe device.

The method of the preceding paragraph can optionally include,additionally and/or alternatively, any one or more of the followingfeatures, configurations and/or additional components:

Wherein making the incision in the patient comprises making the incisionbelow a xiphoid process and/or a sternum of the patient.

Wherein advancing the instrument to the bone, the muscle, and/or thetissue upon which the device is to be anchored comprises advancing theinstrument to the xiphoid process and/or the sternum.

The method further includes removing tissue from the xiphoid processand/or the sternum using a blade on the instrument and/or a bladeseparate from the instrument.

The method further includes positioning the instrument to deploy thedevice onto the xiphoid process and/or the sternum.

Wherein pushing the clip of the device onto the bone, the muscle, and/orthe tissue includes pushing the clip of the device onto the xiphoidprocess and/or the sternum.

Wherein pushing the clip of the device onto the bone, the muscle, and/orthe tissue includes pushing a top portion of the clip of the device ontop of the xiphoid process and/or the sternum and a housing of thedevice below the xiphoid process and/or the sternum.

Wherein anchoring the device to the bone, the muscle, and/or the tissueusing the clip on the device includes anchoring the device to thexiphoid process and/or the sternum using the clip on the device.

The method further includes removing the instrument from the incision inthe patient.

Wherein the clip on the device has a spring portion extending between atop portion and a bottom portion.

Wherein the spring portion has a spring bias that puts tension on thetop portion of the clip to anchor the device to the xiphoid processand/or the sternum.

Wherein pushing the clip of the device onto the bone, the muscle, and/orthe tissue using the instrument includes pushing a slider of theinstrument forward to deploy the device from the instrument.

Wherein the device has a guide that moves through a guide track of theinstrument when the device is pushed through the instrument.

The method further includes pushing a prong of the device through tissuebelow the xiphoid process and the sternum of the patient.

The method further includes securing the device to the bone, the muscle,and/or the tissue using sutures, tines, pins, and/or screws that extendthrough openings in the clip.

A subcutaneously implantable device capable of being injected andanchored to a muscle, a bone, and/or a first tissue using a surgicalinstrument includes a housing, a guide on the housing, a clip attachedto a top side of the housing, and an electrode. The guide is configuredto guide the device through the surgical instrument. The clip isconfigured to anchor the device to the muscle, the bone, and/or thefirst tissue. The electrode is configured to contact an organ, a nerve,the first tissue, and/or a second tissue. Circuitry in the housing is inelectrical communication with the electrode that is configured to sensean electrical signal from the organ, the nerve, the first tissue, and/orthe second tissue through the electrode; deliver electrical stimulationto the organ, the nerve, the first tissue, and/or the second tissuethrough the electrode; and/or deliver a signal to a drug pump to providea targeted or systemic therapeutic drug to the organ, the nerve, thefirst tissue, and/or the second tissue.

The device of the preceding paragraph can optionally include,additionally and/or alternatively, any one or more of the followingfeatures, configurations and/or additional components:

Wherein the clip is configured to attach the device to a xiphoid processand/or a sternum of a patient so that the housing of the device ispositioned below the xiphoid process and/or the sternum of the patient.

Wherein the housing has a curved surface on a top side of the housingadjacent a front end of the housing to form a tapered front end of thehousing.

Wherein the guide on the housing includes a first guide on a first sideof the housing, and a second guide on a second side of the housing,wherein the first guide and the second guide are configured to mount thedevice in and guide the device through a guide track in the surgicalinstrument.

Wherein the clip further includes a top portion, a bottom portion, and aspring portion extending between and connecting the top portion to thebottom portion.

Wherein the top portion of the clip tapers to a tip at a front end.

Wherein the clip further includes a slot extending through the springportion, wherein the slot is configured to receive a blade of thesurgical instrument.

The device further includes a first prong with a proximal end attachedto the housing and a distal end extending away from the housing that isconfigured to contact the organ, the nerve, and/or the second tissue.

Wherein the housing further includes a channel on the bottom side of thehousing extending from a back end to a front end of the housing, whereinwhen the device is positioned in a stowed position in the surgicalinstrument, the first prong is positioned in the channel.

A system for injecting and anchoring a subcutaneously implanted deviceto a muscle, a bone, and/or a first tissue using a surgical instrumentincludes a device and a surgical instrument. The device includes ahousing, a clip attached to a top side of the housing, and an electrode.The clip is configured to anchor the device to the muscle, the bone,and/or the first tissue. The electrode is configured to contact anorgan, a nerve, the first tissue, and/or a second tissue. Circuitry inthe housing is in electrical communication with the electrode that isconfigured to sense an electrical signal from the organ, the nerve, thefirst tissue, and/or the second tissue through the electrode; deliverelectrical stimulation to the organ, the nerve, the first tissue, and/orthe second tissue through the electrode; and/or deliver a signal to adrug pump to provide a targeted or systemic therapeutic drug to theorgan, the nerve, the first tissue, and/or the second tissue. Thesurgical instrument includes a body in which the device is positionable,and a slider positioned in and capable of sliding in the body. Theslider is configured to push the device out of the surgical instrument.

The system of the preceding paragraph can optionally include,additionally and/or alternatively, any one or more of the followingfeatures, configurations and/or additional components:

Wherein a guide on the housing of the device is positionable in andmovable along a guide track in the body of the surgical instrument.

Wherein the device includes a prong with a proximal end attached to thehousing and a distal end extending away from the housing that ispositionable in and movable along a prong track in the body of thesurgical instrument.

Wherein the surgical instrument includes a blade attached to the body ofthe surgical instrument that extends through a slot in the clip of thedevice when the device is stowed in the surgical instrument.

Wherein the slider is positioned in and slides through a slider slot inan upper arm of the body.

Wherein the device is positionable in and slides along a lower arm ofthe body.

A subcutaneously implantable device includes a housing, a clip attachedto a top side of the housing, a first prong with a proximal end attachedto the housing and a distal end extending away from the housing, and afirst electrode on the first prong. The clip is configured to anchor thedevice to a muscle, a bone, and/or a tissue. The first prong isconfigured to contact a heart. The first electrode is configured tocontact the heart. Sensing circuitry in the housing that is configuredto sense an electrical signal from the heart, and therapeutic circuitryin the housing is in electrical communication with the first electrodeand is configured to deliver electrical stimulation to the heart throughthe first electrode.

The device of the preceding paragraph can optionally include,additionally and/or alternatively, any one or more of the followingfeatures, configurations and/or additional components:

Wherein the clip is configured to attach the device to a xiphoid processand/or a sternum of a patient.

Wherein the clip further includes a top portion, a bottom portion, and aspring portion extending between and connecting the top portion to thebottom portion, wherein the spring portion is curved and is configuredto act as a spring for the clip to push the top portion of the clip ontothe bone, the muscle, and/or the tissue to which it is anchored.

Wherein the sensing circuitry is in electrical communication with thefirst electrode and can sense the electrical signal from the heartthrough the first electrode.

Wherein the sensing circuitry is in electrical communication with asecond electrode on the first prong, the housing, and/or the clip andcan sense the electrical signal from the heart through the secondelectrode.

Wherein the first prong is configured to contact a right ventricle ofthe heart, a left ventricle of the heart, a right atrium of the heart,or a left atrium of the heart.

Wherein the therapeutic circuitry is configured to deliver a signal to adrug pump to provide a targeted or systemic therapeutic drug to theorgan, the nerve, the first tissue, and/or the second tissue.

The device further includes a second prong with a proximal end attachedto the housing and a distal end extending away from the housing that isconfigured to contact the heart, and a second electrode on the secondprong that is in electrical communication with the therapeutic circuitryand is configured to deliver the electrical stimulation to the heart.

Wherein the first prong is configured to contact a right ventricle ofthe heart and the second prong is configured to contact a left ventricleof the heart; the first prong is configured to contact a left ventricleof the heart and the second prong is configured to contact a rightatrium of the heart; and/or the first prong is configured to contact aright ventricle of the heart and the second prong is configured tocontact a right atrium of the heart.

The device further includes a third prong with a proximal end attachedto the housing and a distal end extending away from the housing that isconfigured to contact a heart, and a third electrode on the third prongthat is in electrical communication with the therapeutic circuitry andis configured to deliver the electrical stimulation to the heart.

Wherein the first prong is configured to contact the right ventricle ofthe heart, the second prong is configured to contact the left ventricleof the heart, and the third prong is configured to contact the rightatrium of the heart.

A subcutaneously implantable device includes a housing, a clip attachedto a top side of the housing, a first prong with a proximal end attachedto the housing and a distal end extending away from the housing, a firstdefibrillator coil on the distal end of the first prong, and a firstelectrode on a front end of the housing. The clip is configured toanchor the device to a muscle, a bone, and/or a tissue. The first prongis configured to be positioned inferior to a heart. Sensing circuitry inthe housing is in electrical communication with the first electrode andis configured to sense an electrical signal from the heart through thefirst electrode. Therapeutic circuitry in the housing is in electricalcommunication with the first defibrillator coil and the first electrodeand is configured to deliver a shock to the heart through the firstdefibrillator coil.

The device of the preceding paragraph can optionally include,additionally and/or alternatively, any one or more of the followingfeatures, configurations and/or additional components:

Wherein the clip is configured to attach the device to a xiphoid processand/or a sternum of a patient.

Wherein the clip further includes a top portion, a bottom portion, and aspring portion extending between and connecting the top portion to thebottom portion, wherein the spring portion is curved and is configuredto act as a spring for the clip to push the top portion of the clip ontothe bone, the muscle, and/or the tissue to which it is anchored.

Wherein the first defibrillator coil creates a first vector with thefirst electrode, and wherein the first vector passes through the heart.

The device further includes a second prong with a proximal end attachedto the housing and a distal end extending away from the housing that isconfigured to be positioned on a first side of the housing, a thirdprong with a proximal end attached to the housing and a distal endextending away from the housing that is configured to be positioned on asecond side of the housing, a second defibrillator coil on the distalend of the second prong, and a third defibrillator coil on the distalend of the third prong.

Wherein the first defibrillator coil creates a first vector with thefirst electrode, a second vector with the second defibrillator coil, anda third vector with a third defibrillator coil, and wherein the firstvector, the second vector, and the third vector pass through the heart.

The device further includes a second prong with a proximal end attachedto the housing and a distal end extending away from the housing that isconfigured to contact a heart, and a second electrode on the secondprong that is in electrical communication with the therapeutic circuitryand is configured to deliver electrical stimulation to the heart.

Wherein the second prong is configured to contact a right ventricle ofthe heart, a left ventricle of the heart, a right atrium of the heart,or a left atrium of the heart.

A subcutaneously implantable device includes a housing, a clip attachedto a top side of the housing, a first prong with a proximal end attachedto the housing and a distal end extending away from the housing, asecond prong with a proximal end attached to the housing and a distalend extending away from the housing, a first electrode on the firstprong, and a second electrode on the second prong. The clip isconfigured to anchor the device to a muscle, a bone, and/or a firsttissue. The first prong is configured to contact a first organ and/or asecond tissue. The second prong is configured to contact the firstorgan, a second organ, the second tissue, and/or the third tissue. Thefirst electrode is configured to contact the first organ and/or thesecond tissue. The second electrode is configured to contact the firstorgan, the second organ, the second tissue, and/or the third tissue.Sensing circuitry in the housing is in electrical communication with thefirst electrode and the second electrode and is configured to sense anelectrical signal from the first organ, the second organ, the secondtissue, and/or the third tissue.

The device of the preceding paragraph can optionally include,additionally and/or alternatively, any one or more of the followingfeatures, configurations and/or additional components:

Wherein the clip is configured to attach the device to a xiphoid processand/or a sternum of a patient.

Wherein the clip further includes a top portion, a bottom portion, and aspring portion extending between and connecting the top portion to thebottom portion, wherein the spring portion is curved and is configuredto act as a spring for the clip to push the top portion of the clip ontothe bone, the muscle, and/or the first tissue to which it is anchored.

Wherein the first prong is configured to contact the right lung and thesecond prong is configured to contact the left lung; the first prong andthe second prong are configured to contact the heart; and/or the firstprong and the second prong are configured to contact tissue surroundingthe heart.

The device further includes a sensor in electrical communication withthe sensing circuitry and selected from the group consisting of atemperature sensor, an accelerometer, a pressure sensor, a proximitysensor, an infrared sensor, an optical sensor, an ultrasonic sensor, adata storage device, and combinations thereof.

Wherein the sensor is positioned on the housing, the first prong, or thesecond prong.

A subcutaneously implantable device includes a housing, a clip attachedto a top side of the housing, a drug pump having a drug reservoir in thehousing, a prong with a lumen extending through the prong and having aproximal end attached to the housing and the drug pump, and a distal endextending away from the housing. The clip is configured to anchor thedevice to a muscle, a bone, and/or a first tissue. The prong isconfigured to contact an organ, a nerve, and/or a second tissue.Circuitry in the housing in electrical communication with the drug pumpis configured to deliver a signal to the drug pump to provide a targetedor systemic therapeutic drug to the organ, the nerve, the first tissue,and/or the second tissue through the lumen running through the prong.

The device of the preceding paragraph can optionally include,additionally and/or alternatively, any one or more of the followingfeatures, configurations and/or additional components:

Wherein the clip is configured to attach the device to a xiphoid processand/or a sternum of a patient.

Wherein the clip further includes a top portion, a bottom portion, and aspring portion extending between and connecting the top portion to thebottom portion, wherein the spring portion is curved and is configuredto act as a spring for the clip to push the top portion of the clip ontothe bone, the muscle, and/or the first tissue to which it is anchored.

Wherein a port in the housing fluidly connects to the drug reservoir andis configured to allow the drug reservoir to be replenished.

Wherein an electrode positioned on the housing, the clip, and/or theprong is in electrical communication with the circuitry and isconfigured to sense an electrical signal from the organ, the nerve, thefirst tissue and/or the second tissue and/or is configured to deliverelectrical stimulation to the organ, the nerve, the first tissue and/orthe second tissue.

While the invention has been described with reference to an exemplaryembodiment(s), it will be understood by those skilled in the art thatvarious changes may be made and equivalents may be substituted forelements thereof without departing from the scope of the invention. Inaddition, many modifications may be made to adapt a particular situationor material to the teachings of the invention without departing from theessential scope thereof. Therefore, it is intended that the inventionnot be limited to the particular embodiment(s) disclosed, but that theinvention will include all embodiments falling within the scope of theappended claims.

1. A subcutaneously implantable device comprising: a housing; a clipattached to a top side of the housing that is configured to anchor thedevice to a muscle, a bone, and/or a first tissue, wherein the clipcomprises: a top portion; a bottom portion; and a spring portionextending between and connecting the top portion to the bottom portion,wherein the spring portion is configured to force the top portion of theclip down onto the muscle, the bone, and/or the first tissue; anelectrode that is configured to contact an organ, a nerve, the firsttissue, and/or a second tissue; and circuitry in the housing inelectrical communication with the electrode that is configured to sensean electrical signal from the organ, the nerve, the first tissue, and/orthe second tissue through the electrode; deliver electrical stimulationto the organ, the nerve, the first tissue, and/or the second tissuethrough the electrode; and/or deliver a signal to a drug pump to providea targeted or systemic therapeutic drug to the organ, the nerve, thefirst tissue, and/or the second tissue.
 2. The device of claim 1,wherein the clip is configured to attach the device to a xiphoid processand/or a sternum of a patient.
 3. The device of claim 2, wherein theclip is configured with respect to the housing such that when the clipis attached to the xiphoid process and/or the sternum, the housing ofthe device is positioned below the xiphoid process and/or the sternum ofthe patient.
 4. The device of claim 1, wherein the electrode ispositioned on the housing.
 5. The device of claim 1, wherein theelectrode is positioned on the top portion of the clip.
 6. The device ofclaim 1, wherein the clip further comprises: a first opening and asecond opening extending through the top portion of the clip, whereinthe first opening and the second opening are configured to receivesutures, tines, pins, or screws to secure the device to the bone, themuscle, and/or the first tissue on which the clip is anchored.
 7. Thedevice of claim 1, and further comprising: a prong with a proximal endattached to the housing and a distal end extending away from the housingthat is configured to contact the organ, the nerve, and/or the secondtissue, wherein the electrode is positioned on the distal end of theprong.
 8. The device of claim 7, wherein the prong further comprises: abase portion on the proximal end of the prong; a spring portionextending from the base portion; an arm portion extending from thespring portion; and a contact portion extending from the arm portion andterminating at the distal end of the prong.
 9. The device of claim 8,wherein the spring portion is curved and is configured to act as aspring for the prong.
 10. The device of claim 8, wherein the electrodeis positioned on the contact portion of the prong.
 11. A subcutaneouslyimplantable device comprising: a housing; a clip attached to a top sideof the housing that is configured to anchor the device to a muscle, abone, and/or a first tissue, wherein the clip comprises: a top portion;a bottom portion; and a spring portion extending between and connectingthe top portion to the bottom portion, wherein a spring bias of thespring portion of the clip is configured to anchor the clip to themuscle, the bone, and/or the first tissue; an electrode that isconfigured to contact an organ, a nerve, the first tissue, and/or asecond tissue; and circuitry in the housing in electrical communicationwith the electrode that is configured to sense an electrical signal fromthe organ, the nerve, the first tissue, and/or the second tissue throughthe electrode; deliver electrical stimulation to the organ, the nerve,the first tissue, and/or the second tissue through the electrode; and/ordeliver a signal to a drug pump to provide a targeted or systemictherapeutic drug to the organ, the nerve, the first tissue, and/or thesecond tissue.
 12. The device of claim 11, wherein the clip isconfigured to attach the device to a xiphoid process and/or a sternum ofa patient.
 13. The device of claim 12, wherein the clip is configuredwith respect to the housing such that when the clip is attached to thexiphoid process and/or the sternum, the housing of the device ispositioned below the xiphoid process and/or the sternum of the patient.14. The device of claim 11, wherein the electrode is positioned on thehousing.
 15. The device of claim 11, wherein the electrode is positionedon the top portion of the clip.
 16. The device of claim 11, wherein theclip further comprises: a first opening and a second opening extendingthrough the top portion of the clip, wherein the first opening and thesecond opening are configured to receive sutures, tines, pins, or screwsto secure the device to the bone, the muscle, and/or the first tissue onwhich the clip is anchored.
 17. The device of claim 11, and furthercomprising: a prong with a proximal end attached to the housing and adistal end extending away from the housing that is configured to contactthe organ, the nerve, and/or the second tissue, wherein the electrode ispositioned on the distal end of the prong.
 18. The device of claim 17,wherein the prong further comprises: a base portion on the proximal endof the prong; a spring portion extending from the base portion; an armportion extending from the spring portion; and a contact portionextending from the arm portion and terminating at the distal end of theprong.
 19. The device of claim 18, wherein the spring portion is curvedand is configured to act as a spring for the prong.
 20. The device ofclaim 18, wherein the electrode is positioned on the contact portion ofthe prong.
 21. A subcutaneously implantable device comprising: ahousing; a clip attached to a top side of the housing that is configuredto anchor the device to a muscle, a bone, and/or a first tissue with aretaining member of the clip that is positionable on a side of themuscle, the bone, and/or the first tissue opposite of the housing; anelectrode that is configured to contact an organ, a nerve, the firsttissue, and/or a second tissue; and circuitry in the housing inelectrical communication with the electrode that is configured to sensean electrical signal from the organ, the nerve, the first tissue, and/orthe second tissue through the electrode; deliver electrical stimulationto the organ, the nerve, the first tissue, and/or the second tissuethrough the electrode; and/or deliver a signal to a drug pump to providea targeted or systemic therapeutic drug to the organ, the nerve, thefirst tissue, and/or the second tissue.
 22. The device of claim 21,wherein the clip is configured to attach the device to a xiphoid processand/or a sternum of a patient.
 23. The device of claim 22, wherein theclip is configured with respect to the housing such that when the clipis attached to the xiphoid process and/or the sternum, the housing ofthe device is positioned below the xiphoid process and/or the sternum ofthe patient.
 24. The device of claim 21, wherein the electrode ispositioned on the retaining member of the clip.
 25. The device of claim21, wherein the retaining member of the clip is a top portion of theclip, and wherein the clip further comprises: a bottom portion; and aspring portion extending between and connecting the top portion to thebottom portion.
 26. The device of claim 25, wherein the spring portionis curved and is configured to act as a spring for the clip to push thetop portion of the clip onto the bone, the muscle, and/or the firsttissue to which it is anchored.
 27. The device of claim 21, and furthercomprising: a prong with a proximal end attached to the housing and adistal end extending away from the housing that is configured to contactthe organ, the nerve, and/or the second tissue, wherein the electrode ispositioned on the distal end of the prong.
 28. The device of claim 27,wherein the prong further comprises: a base portion on the proximal endof the prong; a spring portion extending from the base portion; an armportion extending from the spring portion; and a contact portionextending from the arm portion and terminating at the distal end of theprong.
 29. The device of claim 28, wherein the spring portion is curvedand is configured to act as a spring for the prong.
 30. The device ofclaim 28, wherein the electrode is positioned on the contact portion ofthe prong.